regulatory product manager

Grifols Egypt for Plasma Derivatives (GEPD)

<div>
 <strong>
  Job Objective:
  <br/>
  <br/>
 </strong>
 Regulatory Affairs Senior Manager is the responsible for any communication and coordination with EDA , European Medicines Agency (EMA) and/or other International Health Authorities (as required).
 <br/>
 <br/>
 Liaison and support between regulatory bodies and operating divisions of the company. Responsible for reviewing and managing the regulatory function by ensuring compliance with (EDA), European Medicines Agency (EMA) and other International Health Authorities (as required), regulations and guidelines to obtain and maintain the corresponding approvals for any GMP area, including Plasma Supply Chain, Manufacturing facility, Exportation / Importation for plasma and/or Final Product in Egyptian Market or others (as required).
 <br/>
 <br/>
 <strong>
  Key responsibility:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities for Plasma Supply chain and Manufacturing facilities for the process of licensing, certification, exportation, importation, and finished product release.
  </li>
  <li>
   Ensure that applicable Health Authorities guidelines, rules and regulations are applied up to date, covering plasma or finished products or GMP sites and regulatory processes.
  </li>
  <li>
   Review and manage the licensing and GMP certification regulatory process for Plasma supply chain and manufacturing. Ensure any submissions related to local and international Health Authority are performed on time for initial licensing and renewal (if applicable) to maintain valid license and/ or certification is maintained in all facilities per existing regulations.
  </li>
  <li>
   Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
  </li>
  <li>
   Change notification to Local and International Health Authorities.
  </li>
  <li>
   Change notification and customers related to Change Control implementation.
  </li>
  <li>
   To assist Direct Manager in any assigned duties.
  </li>
  <li>
   Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Academic &amp; Professional Experience Required
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
  </li>
  <li>
   Post-Graduate Certification in Quality Management.
  </li>
  <li>
   Knowledge of cGMP requirements preferred.
  </li>
  <li>
   Minimum of 4 years of Management or technical leadership experience is required.
  </li>
  <li>
   Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
  </li>
  <li>
   Manufacturing background, and Final Product importation and exportation experience.
  </li>
  <li>
   Preferably with experience on EMA Regulatory requirements and submissions.
   <br/>
  </li>
 </ul>
</div>


Regulatory Affairs Sr. Manager

Avalara

<div>What You&rsquo;ll Do:
<div>
As Principal Product Manager - E-Invoicing, you will play an important role in Avalara's continued growth across EMEA and beyond. You'll be the mandate owner for Turkey, serving as the regulatory and technical authority for one of the most advanced e-invoicing markets globally. Additionally, you'll be a lead for regulatory monitoring and analysis across additional jurisdictions.</div><div></div><div><br>
Working with Avalara's Content Research, Engineering, and Business teams, you'll translate complex legislation into clear product requirements&mdash;turning regulatory change into customer value. This is a role that sits at the intersection of regulation, technology, and product strategy.</div><div>
This is a senior individual contributor and fully remote role. You will report to the VP of E-invoicing and Live Reporting.</div><div>
#LI-remote</div>
What Your Responsibilities Will Be:
<ul><li>You will own the Turkey e-invoicing mandate end-to-end, being the primary subject matter expert for regulatory, technical, and operational requirements.</li><li>
You will lead regulatory monitoring and analysis across additional e-invoicing markets, with a focus on mature and emerging regimes.</li><li>
You will partner with the Content Research team to raise requests for legislative monitoring and deep-dive research, review, analyze, and triage regulatory updates, and translate findings into clear business and technical requirements.</li><li>
You will research and document detailed product requirements, including User stories, business and technical mandate requirements, use cases and acceptance criteria for engineering execution.</li><li>
Perform gap analysis between regulatory requirements and existing product functionality.</li><li>
Support product ideation by defining and prioritizing enhancements to features, functionality, and country coverage.</li><li>
Be a business SME, engaging directly with customers, partners, and team members to validate requirements and solutions.</li><li>
Work iteratively with Engineering, Design/UX, and Product peers to deliver pragmatic, compliant solutions on committed timelines.</li><li>
Ensure delivery of product initiatives by coordinating across engineering and cross-functional teams.</li><li>
Define and track metrics to measure product success and regulatory readiness.</li><li>
Engage with trade associations, industry groups, and regulatory bodies</li><li>
Participate in (and speaking at) public, government, customer, and partner forums</li><li>
Help with certification and accreditation processes with relevant authorities and organizations (e.g., OpenPeppol, EESPA).</li></ul>
What You'll Need to be Successful:
<ul><li>8+ years' experience in the Big 4 or a similar environment, focused on indirect tax and tax technology.</li><li>
3+ years' experience in e-invoicing, gained through professional services, product management, pre-sales engineering, or similar roles.</li><li>
Experience researching and analysing country-specific e-invoicing mandates in mature markets.</li><li>
Background working in SaaS environments, delivering scalable solutions.</li><li>
The ability to translate regulatory complexity into clear, relevant product requirements.</li></ul>
Avalara is an AI-first Company:
<div>
AI is embedded in our workflows, decision-making, and products. Success here requires embracing AI as an essential capability.</div><ul><li><div>
You&rsquo;ll bring experience using AI and AI-related technologies, ready to thrive here.</div></li><li><div>
You&rsquo;ll apply AI every day to business challenges - improving efficiency, contributing solutions, and driving results for your team, our company, and our customers.</div></li><li><div>
You&rsquo;ll grow with AI by staying curious about new trends and best practices, and by sharing what you learn so others can benefit too.</div></li></ul>
How We'll Take Care of You:
<p>
Total Rewards</p><p>
In addition to a great compensation package, paid time off, and paid parental leave, many Avalara employees are eligible for bonuses.</p><div></div><div><br>
Health &amp; Wellness<br>
Benefits vary by location but generally include private medical, life, and disability insurance.</div><div></div><div><br>
Inclusive culture and diversity<br>
Avalara strongly supports diversity, equity, and inclusion, and is committed to integrating them into our business practices and our organizational culture. We also have a total of 8 employee-run resource groups, each with senior leadership and exec sponsorship.</div><br>
<div></div>
What You Need To Know About Avalara:
<div>
We&rsquo;re defining the relationship between tax and tech.</div><div></div><div><br>
We&rsquo;ve already built an industry-leading cloud compliance platform, processing over 54 billion customer API calls and over 6.6 million tax returns a year. Our growth is real - we're a billion dollar business - and we&rsquo;re not slowing down until we&rsquo;ve achieved our mission - to be part of every transaction in the world.</div><div></div><div><br>
We&rsquo;re bright, innovative, and disruptive, like the orange we love to wear. It captures our quirky spirit and optimistic mindset. It shows off the culture we&rsquo;ve designed, that empowers our people to win. We&rsquo;ve been different from day one. Join us, and your career will be too.</div><div></div><div><b><br>
We&rsquo;re An Equal Opportunity Employer</b></div><div>
Supporting diversity and inclusion is a cornerstone of our company &mdash; we don&rsquo;t want people to fit into our culture, but to enrich it. All qualified candidates will receive consideration for employment without regard to race, color, creed, religion, age, gender, national orientation, disability, sexual orientation, US Veteran status, or any other factor protected by law. If you require any reasonable adjustments during the recruitment process, please let us know.</div></div>

Principal Product Manager - E-invoicing

Amgen

<div><p><b>HOW MIGHT YOU DEFY IMAGINATION? </b>If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.</p><p></p><p>
Regulatory Affairs &quot;Labelling&quot; Manager| MEA</p><p></p><p><b>
Scope:
</b></p><p></p><p>Accountable for end‑to‑end execution of compliant, accurate, and timely local product labeling and packaging deliverables across assigned MEA markets. Ensures alignment with Global Core Labeling (GCL) and company labeling governance while incorporating local Health Authority requirements, language conventions, and lifecycle changes.</p><p></p><p><b>
Key Responsibilities:</b></p><ul><li>
Own and execute local labeling activities for assigned products/country clusters (e.g., SmPC/PI, PIL/leaflet, carton/label text, IFU), ensuring content accuracy, completeness, and compliance.</li><li>
Translate global core updates into local implementation plans: perform impact assessments, draft/redline local texts, coordinate review/approval, and support submission strategy for labeling variations/line extensions.</li><li>
Act as local/regional **source text owner** for artwork creation: deliver &lsquo;right‑first‑time&rsquo; source texts and maintain traceability from CDS/CCDS/GCL changes to country label implementation.</li><li>
Coordinate packaging and artwork lifecycle activities (leaflet, label, blister, outer pack): initiate and manage updates, support shared pack/SKU strategy execution, and ensure supply‑readiness timelines are met.</li><li>
Manage translation workflows (including engaging translation agency systems): request translations, track readiness, and perform **100% translation review** for both content and format (as required for regional languages).</li><li>
Execute labeling/artwork review and approval tasks in designated systems (e.g., Veeva Vault, RIM/Regulatory Information Management, artwork management tools), maintaining version control and inspection‑ready documentation.</li><li>
Monitor and report operational metrics (e.g., right‑first‑time labels, cycle time, on‑time delivery) and drive corrective actions for recurring defects or bottlenecks.</li><li>
Support biosimilars labeling redaction/maintenance activities (as applicable to assigned portfolio).</li><li>
Support track‑and‑trace/serialization intelligence gathering and execution for assigned clusters; ensure packaging/labeling requirements are reflected in artworks and implementation plans.</li><li>
Draft, update, and/or support local SOPs and work instructions related to labeling management; ensure adherence to internal procedures and quality standards.</li><li>
Identify labeling and packaging risks (compliance, timelines, translations, artwork quality) and proactively propose mitigations; escalate issues per governance.</li></ul><p></p><p><b>
Qualifications:</b></p><ul><li>
Bachelor&rsquo;s degree in Pharmacy or related life sciences (required); advanced degree is an advantage.</li><li>
Typically 4&ndash;8+ years of Regulatory Affairs experience with strong hands‑on labeling and artwork/packaging lifecycle management.</li><li>
Current or previous experience within MNCs is a must.</li><li>
Knowledge of Middle East &amp; Africa regulatory requirements and practical experience coordinating multi‑country implementations.</li><li>
Language skills: English (required); French literacy strongly preferred; Arabic preferred when the role includes Arabic translation review responsibilities.</li><li>
Demonstrated proficiency working in regulated document and workflow systems (e.g., Veeva Vault, RIM tools) and in cross‑functional matrix environments.</li><li>
Skills/behaviors: detail orientation, planning/priority management, proactive risk management, clear written/oral communication, cultural awareness, and a quality mindset.</li></ul><p></p><p><b>
Thrive What You Can Expect Of Us </b>As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.</p><br>
<ul><li>
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul><p><b>
Apply now for a career that defies imagination </b>In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.<br>
<br>
<b>careers.amgen.com </b>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</p></div>

Regulatory Affairs "Labelling" Manager| MEA

American Express

<div><div>At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. From delivering differentiated products to providing world-class customer service, we operate with a strong risk mindset, ensuring we continue to uphold our brand promise of trust, security, and service.
</div><div>As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your career. Here, your voice and ideas matter, your work makes an impact, and together, you will help us define the future of American Express.
</div><p><b>How will you make an impact in this role?
</b></p><p>As a brand built on going above and beyond to provide the best customer experience, having the most exceptional colleagues is paramount. As the face of the company, you can create positive interactions with our customers every day&ndash;from curating a unique travel or lifestyle experience to helping them with their everyday needs. And, you can grow your skills through industry-leading training and ongoing coaching, all while learning what it means to continually set the standard for world class, customer-first service. Find your place in service on #TeamAmex.
</p><p><b>Team Description
</b></p><p>The newly created First line of Defense Financial Crimes Risk &amp; Controls Center of Excellence (1LOD FCRC COE) will provide a holistic, enterprise-wide approach to our financial crimes risk management (FCRM) activities and will reside within Global Servicing.
</p><p>This team will be responsible for establishing a robust control foundation for first line of defense FCRM activities across the company globally, including anti-money laundering, sanctions, payments controls, and anti-corruption. The team will partner closely with Technology to develop and deploy next generation capabilities that address key gaps and strengthen the first line&rsquo;s ability to detect and prevent financial crimes across our lines of business. The team will work in coordination with the Global Financial Crimes Compliance (GFCC) team within the Global Risk &amp; Compliance organization.
</p><p><b>Responsibilities:
</b></p><p>This position partners closely with GMNS , Risk, Compliance, Legal, Operations, Technology, Data, and Enterprise Platform teams on strategic initiatives focused on delivering and scaling FCRM capabilities, strengthening regulatory controls, and modernizing the FCRM technology and data landscape.
</p><p>We are looking for a high-caliber product delivery and solution management leader who can operate in a complex, highly regulated environment, lead cross-functional delivery teams, and balance regulatory commitments with long-term product strategy.
</p><p><b>Primary responsibilities include:
</b></p><ul><li><p>Own end-to-end product delivery and solution management for FCRM capabilities, including planning, solution design, execution, testing, release management, and production readiness across multiple workstreams
</p></li><li><p>Define and execute the product vision, target-state capabilities, and multi-year roadmap, balancing regulatory delivery commitments with long-term platform scalability, modernization, and enterprise reuse.
</p></li><li><p>Lead the E2E delivery execution by proactively managing delivery risks, dependencies, scope governance, and trade-offs to ensure timely, compliant, and high-quality outcomes.
</p></li><li><p>Collaborate closely with stakeholders across Risk, Compliance, Technology, Data, Analytics, Operations, and Enterprise Platforms (e.g., Customer 360, Channels, Servicing) to deliver integrated, end-to-end financial crime solutions.
</p></li><li><p>Ensure solutions are designed and delivered with strong controls, auditability, data quality, and governance, aligned to first-line risk ownership and second-line oversight expectations.
</p></li><li><p>Lead stakeholder engagement and communication, providing clear transparency into product strategy, delivery status, risk posture, and key decision points for senior leadership.
</p></li><li><p>Focused product mindset on outcomes to continuously evolve FCRM capabilities based on regulatory feedback, operational insights, and evolving risk landscapes.
</p></li></ul><p><b>Minimum Qualifications:
</b></p><ul><li><p>This high energy individual must have the following qualifications:
</p></li><li><p>8&ndash;12+ years of experience in product management, solution delivery, or technology delivery, with significant experience in Financial Crime, Risk, Compliance, or Regulatory domains.
</p></li><li><p>Strong understanding of FCRM concepts, including KYC/KYB, AML, sanctions, customer risk rating, investigations, controls, and regulatory obligations.
</p></li><li><p>Proven experience leading large-scale, cross-functional delivery programs in complex, highly regulated environments.
</p></li><li><p>Demonstrated ability to translate regulatory and risk requirements into scalable product and technology solutions.
</p></li><li><p>Excellent communication and stakeholder management skills, with the ability to engage, influence, and align senior leaders across Risk, Compliance, Technology, and Operations.
</p></li><li><p>Degree in business, risk management, computer science, engineering, or a related field, or equivalent professional experience.
</p></li></ul><p><b>Preferred Qualifications:
</b></p><ul><li><p>Experience working with enterprise data platforms, customer data, or risk data is strongly preferred.
</p></li><li><p>Experience with GMNS Business processes and platform enabling key consumer products will be preferred
</p></li><li><p>Advanced degree in business, risk management, computer science, engineering, or a related field, or equivalent professional experience
</p></li></ul><p><b>What is it about you?
</b></p><ul><li><p>You hold yourself and your teams accountable for delivery and outcomes.
</p></li><li><p>You can quickly understand complex regulatory and risk problems.
</p></li><li><p>You can translate complex regulatory and technical solutions into clear, actionable narratives for business and risk partners.
</p></li><li><p>You bring structure and rigor to ambiguous problem spaces.
</p></li><li><p>You are resilient and composed in high-pressure, regulatory-driven environments.
</p></li><li><p>You build trust with senior stakeholders and inspire cross-functional teams.
</p></li><li><p>You balance competing priorities while maintaining focus on risk outcomes and delivery excellence.
</p></li></ul><p>Salary Range: $123,000.00 to $215,250.00 annually + bonus + equity (if applicable) + benefits
</p><p>The above represents the expected salary range for this job requisition. Ultimately, in determining your pay, we&rsquo;ll consider your location, experience, and other job-related factors.
</p><p>We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally:
</p><ul><li>Competitive base salaries
</li><li>Bonus incentives
</li><li>6% Company Match on retirement savings plan
</li><li>Free financial coaching and financial well-being support
</li><li>Comprehensive medical, dental, vision, life insurance, and disability benefits
</li><li>Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need
</li><li>20+ weeks paid parental leave for all parents, regardless of gender, offered for pregnancy, adoption or surrogacy
</li><li>Free access to global on-site wellness centers staffed with nurses and doctors (depending on location)
</li><li>Free and confidential counseling support through our Healthy Minds program
</li><li>Career development and training opportunities
</li></ul><p>For a full list of Team Amex benefits, visit our Colleague Benefits Site .
</p><p>American Express is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law. American Express will consider for employment all qualified applicants, including those with arrest or conviction records, in accordance with the requirements of applicable state and local laws, including, but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance. For positions covered by federal and/or state banking regulations, American Express will comply with such regulations as it relates to the consideration of applicants with criminal convictions.
</p><p>We back our colleagues with the support they need to thrive, professionally and personally. That's why we have Amex Flex, our enterprise working model that provides greater flexibility to colleagues while ensuring we preserve the important aspects of our unique in-person culture. Depending on role and business needs, colleagues will either work onsite, in a hybrid model (combination of in-office and virtual days) or fully virtually.
</p><p>US Job Seekers - Click to view the &ldquo; Know Your Rights &rdquo; poster. If the link does not work, you may access the poster by copying and pasting the following URL in a new browser window: https://www.eeoc.gov/poster
</p><p>Depending on factors such as business unit requirements, the nature of the position, cost and applicable laws, American Express may provide visa sponsorship for certain positions</p></div>

Director - Product Delivery and Solution Management - GMNS

<div><p>At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. From delivering differentiated products to providing world-class customer service, we operate with a strong risk mindset, ensuring we continue to uphold our brand promise of trust, security, and service.
</p><p>As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your career. Here, your voice and ideas matter, your work makes an impact, and together, you will help us define the future of American Express.
</p><p><b>How will you make an impact in this role?
</b></p><p>Global Commercial Services (GCS) is the global leader in payment solutions for Small, Medium (SME) and Global and Large (G&amp;L) enterprises. The objective of the GCS Control Management Go To Market/New Product Governance (GTM / NPG) team is to provide subject matter expertise on specific GTM / NPG to ensure the BU is equipped with in-depth knowledge of risk-stripes to manage and mitigate these risks effectively; supports the BU with expert guidance for topical Operational Risk intelligence.
</p><p>The objective of the first line of defense (1LOD) in GCS Control Management Risk ID, Assessment, Testing and Reporting team is to identify, assess, mitigate, and report on Operational Risk within BU processes for GCS to ensure adherence to regulatory standards, Amex policy and enhance the BU&rsquo;s resilience through managing a clear methodology of inherent and residual risk.
</p><p><b>The Senior Analyst - Control Management (New Product Governance) will:
</b></p><p>GCS is looking for a first line of defense (1LOD) Senior Analyst - Control Management (New Product Governance) within Risk ID, Assessment, Testing &amp; Reporting. The Senior Analyst will perform inherent risk assessments on new business initiatives and ensure risk is mitigated prior to launch. It will involve extensive collaboration with multiple partners across numerous business units, functional areas, and geographies.
</p><h3 class="jobSectionHeader"><b>Responsibilities:
</b></h3><ul><li>Perform risk assessments on new business initiatives, including product development, to ensure accurate risk identification and mitigation in partnership with Risk Stripes, including but not limited to, Compliance, General Counsel, Information Security, Finance, Fraud, and Third-Party Risk
</li><li>Support business stakeholders with identification of risks where changes or mitigating controls are needed prior to deployment
</li><li>Monitor internal issues and events to proactively identify areas of concern that may impact future business initiatives
</li><li>Remain informed of the external regulatory landscape and current events impacting the financial services industry
</li><li>Be a key leader for sharing insights, better practices, themes, etc. across other control management teams
</li></ul><h3 class="jobSectionHeader"><b>Required Qualifications:
</b></h3><ul><li><p>2+ Years experience in operational risk management (e.g., within Risk and/or Internal Audit function)
</p></li><li><p>Understanding of critical operational risk management lifecycle activities
</p></li><li><p>Excellent project management, communication, and interpersonal skills
</p></li><li><p>Experience in process governance, with an understanding of processes that align with policies, regulatory frameworks, and/or operational standards
</p></li><li><p>Robust analytical and problem-solving skills, with an ability to analyze data, identify trends, and evaluate risk scenarios effectively<br>
</p></li></ul><h3 class="jobSectionHeader"><b>Preferred Qualifications:
</b></h3><ul><li><p>Bachelor's Degree in Finance, Business, Risk Mgmt., or related field; advanced degrees (e.g., MBA, MSc) or certifications are advantageous
</p></li><li><p>Experience in at least two of the following:
</p></li><li><p>Providing identification of operational risks throughout business processes and systems
</p></li><li><p>Facilitating risk assessment performance in addition to further assessments and testing programs to ensure regulatory and internal standards are met
</p></li><li><p>Managing large scale risk assessments for products, projects or services
</p></li><li><p>Managing independent control monitoring, including identification of control improvements
</p></li><li><p>Overseeing identification of areas of risk for intervention, including conducting independent quality assurance and process testing
</p></li><li><p>Experience in financial services industry
</p></li></ul><p>ORMCM
</p><p>Salary Range: $78,000.00 to $124,750.00 annually + bonus + benefits
</p><p>The above represents the expected salary range for this job requisition. Ultimately, in determining your pay, we&rsquo;ll consider your location, experience, and other job-related factors.
</p><p>Employment eligibility to work with American Express in the United States is required as the company will not pursue visa sponsorship for these positions.
</p><p>We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally:
</p><ul><li>Competitive base salaries
</li><li>Bonus incentives
</li><li>6% Company Match on retirement savings plan
</li><li>Free financial coaching and financial well-being support
</li><li>Comprehensive medical, dental, vision, life insurance, and disability benefits
</li><li>Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need
</li><li>20+ weeks paid parental leave for all parents, regardless of gender, offered for pregnancy, adoption or surrogacy
</li><li>Free access to global on-site wellness centers staffed with nurses and doctors (depending on location)
</li><li>Free and confidential counseling support through our Healthy Minds program
</li><li>Career development and training opportunities
</li></ul><p>For a full list of Team Amex benefits, visit our Colleague Benefits Site .
</p><p>American Express is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law. American Express will consider for employment all qualified applicants, including those with arrest or conviction records, in accordance with the requirements of applicable state and local laws, including, but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance. For positions covered by federal and/or state banking regulations, American Express will comply with such regulations as it relates to the consideration of applicants with criminal convictions.
</p><p>We back our colleagues with the support they need to thrive, professionally and personally. That's why we have Amex Flex, our enterprise working model that provides greater flexibility to colleagues while ensuring we preserve the important aspects of our unique in-person culture. Depending on role and business needs, colleagues will either work onsite, in a hybrid model (combination of in-office and virtual days) or fully virtually.
</p><p>US Job Seekers - Click to view the &ldquo; Know Your Rights &rdquo; poster. If the link does not work, you may access the poster by copying and pasting the following URL in a new browser window: https://www.eeoc.gov/poster</p></div>

Senior Analyst - Control Management (New Product Governance)

<div><p><b>HOW MIGHT YOU DEFY IMAGINATION? </b>If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.</p><p></p><p>
Regulatory Affairs Senior Manager| MEA</p><p></p><p><b>
Scope</b></p><p>
Provides strategic leadership and oversight for labeling activities across MEA markets, ensuring regional alignment to Global Labeling Strategy and governance. Drives risk management, operational excellence, capability building, and timely patient access across diverse regulatory environments.</p><p></p><p><b>
Key Responsibilities:</b></p><ul><li>
Define and maintain MEA regional labeling strategy and operational priorities across clusters/products, aligned to global governance and business priorities (launches, safety updates, lifecycle changes).</li><li>
Serve as the senior MEA labeling representative in global governance forums and labeling working groups; advocate for regional needs and enable timely global decisions.</li><li>
Provide strategic oversight and direction for complex labeling changes (e.g., safety‑driven updates, class labeling, multi‑market harmonization, shared pack strategy) and launch readiness .</li><li>
Lead and approve regional impact assessments for global core label changes; set implementation approach, timelines, and escalation pathways for high‑risk updates.</li><li>
Accountable for inspection readiness: ensure compliant processes, robust documentation/traceability, audit support, and timely closure of observations/CAPAs related to labeling and packaging controls.</li><li>
Drive continuous improvement, standardization, and efficiency across MEA labeling processes (e.g., templates, playbooks, KPI frameworks, quality checks) to improve predictability and reduce rework.</li><li>
Provide leadership for vendor and partner performance (e.g., translation agencies, artwork houses) including quality expectations, service levels, and continuous improvement actions (budget oversight where applicable).</li><li>
Ensure effective cross‑functional coordination across Regulatory, Safety, Quality, Supply Chain, and affiliate teams to maintain supply continuity and patient access.</li><li>
People leadership: recruit/structure resources as needed, coach and develop L5/junior team members, set objectives, conduct performance reviews, and build succession and capability plans.</li><li>
Acts as escalation point for labeling risks, delays, and Health Authority interactions that threaten compliance, supply continuity, or patient safety.</li><li>
Influences global and regional stakeholders to align decisions, trade‑offs, and implementation timelines.</li></ul><p></p><p><b>
Qualifications:</b></p><ul><li>
Bachelor&rsquo;s degree in pharmacy or related life sciences (required); advanced degree preferred.</li><li>
Typically, 8&ndash;10+ years of Regulatory Affairs experience with demonstrated regional or global labeling leadership.</li><li>
Current or previous experience within MNCs is a must.</li><li>
Proven strategic thinking, governance participation, and risk management capability across complex, multi‑country portfolios.</li><li>
Language skills: English (required); French literacy strongly preferred; additional regional languages an advantage.</li><li>
Demonstrated people leadership (coaching, performance management) and ability to influence without authority across matrix teams.</li></ul><p></p><p><b>
Thrive What You Can Expect Of Us </b>As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.</p><br>
<ul><li>
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul><p><b>
Apply now for a career that defies imagination </b>In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.<br>
<br>
<b>careers.amgen.com </b>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</p></div>

Regulatory Affairs Senior Manager| MEA

Morphe

<div>Description:
<p>
The Clinical and Consumer Claims Manager is responsible for overseeing the strategy, development, and execution of clinical and consumer claims within the Development team. This role ensures that all claims&mdash;clinical, regulatory, and consumer-facing&mdash;are accurate, compliant, evidence-based, and aligned with organizational goals. The Manager partners cross-functionally with Clinical, Legal/Compliance, Marketing, Product, and Operations teams to support product development, market readiness, and ongoing optimization.</p><p>
This role will also oversee Development teams external and internal testing protocols and will collaborate with Development and Brand on best methods to achieve desirable results. This role will be critical upon product concepting and building out testing requirements on briefs to CM&rsquo;s.</p><p>
Key Responsibilities</p><p>
Claims Strategy &amp; Development</p><ul><li>Lead the development, review, and approval of clinical and consumer claims across products, programs, and initiatives.</li><li>Translate clinical evidence, outcomes data, and real-world evidence into clear, compliant, and compelling claims.</li><li>Ensure claims are consistent with regulatory requirements, clinical standards, and organizational positioning.</li><li>Oversee preliminary Internal and External testing in collaboration with Development teams.</li></ul><p>
Clinical &amp; Regulatory Oversight</p><ul><li>Evaluate clinical studies, data analyses, and supporting documentation to substantiate claims.</li><li>Partner with Legal, Compliance, and Regulatory teams to ensure adherence to applicable laws, guidelines, and industry standards.</li><li>Maintain up-to-date knowledge of evolving clinical, regulatory, and payer landscapes impacting claims.</li></ul><p>
Cross-Functional Collaboration</p><ul><li>Work closely with Product Development, Brand, Regulatory and Copy teams to align claims with product strategy and consumer needs.</li><li>Provide guidance and training to internal stakeholders on appropriate use of clinical and consumer claims.</li><li>Serve as a subject matter expert during product launches, audits, and external reviews.</li></ul><p>
Process Implementation and Ownership</p><ul><li>Establish and maintain standardized processes for claims review, approval, and documentation.</li><li>Identify opportunities to improve efficiency, clarity, and scalability of claims development workflows.</li><li>Track and report on key performance indicators related to claims quality, compliance, and impact.</li></ul>
Requirements:
<p>
Qualifications</p><ul><li>Bachelor&rsquo;s degree</li><li>Experience in a beauty space managing clinical, scientific data. Other areas for consideration (healthcare, or related field)</li><li>5+ years of experience in clinical claims or related roles.</li><li>Strong understanding of clinical evidence, claims, and regulatory/compliance requirements.</li><li>Proven ability to collaborate across multiple teams (Brand, Marketing, Regulatory, Development)</li><li>Excellent written and verbal communication skills, with the ability to translate complex clinical concepts for diverse audiences.</li><li>Knowledge of Beauty industry</li></ul></div>

Clinical and Consumer Claims Manager

Search 10000+ Regulatory product manager jobs near you this March. New roles added regularly across leading industries. Apply today.