global regulatory affairs manager

Shifamed LLC

<div><div><div>Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana&trade; Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ&trade;, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&amp;D and manufacturing center in Doha, Qatar.</div>
<div></div><div>ABOUT SHIFAMED</div>
<div>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.</div>
</div><div></div>Description:
This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross-functional team, partnering closely with Clinical, Quality, R&amp;D, and Executive Leadership to support U.S. regulatory activities and lead global clinical studies and international market expansion. The ideal candidate brings strong FDA medical device experience combined with hands-on knowledge of international regulatory pathways, agency interactions, and clinical study support across Europe, the Middle East, and other global markets. This is a unique opportunity to help shape regulatory strategy for a clinical-stage medical device company as it expands global clinical activities, and prepares for international commercialization.
Responsibilities, Skills &amp; Hands-On Experience:
 
Regulatory Strategy &amp; Product Development:
<ul><li>Develop and execute global regulatory strategies for Akura Medical's thrombectomy and catheter-based cardiovascular technologies.</li>
<li>Serve as regulatory lead on cross-functional product development teams from concept through commercialization.</li>
<li>Provide regulatory guidance on design controls, risk management, verification and validation activities, labeling, and product changes.</li>
<li>Partner with Quality and R&amp;D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements.</li>
</ul>FDA Regulatory Affairs
<ul><li>Lead preparation, review, and submission of U.S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable.</li>
<li>Monitor evolving FDA requirements and assess impact on development and commercialization plans.</li>
</ul>International Regulatory Expansion
<ul><li>Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets.</li>
<li>Support CE Mark and MDR-related activities in partnership with Notified Bodies and external regulatory consultants.</li>
<li>Lead country-specific registration activities and regulatory submissions across key international markets including Qatar, UAE, Saudi Arabia, and other MENA countries.</li>
<li>Establish and maintain relationships with regulatory authorities, notified bodies, and international regulatory partners.</li>
</ul>Clinical &amp; Regulatory Operations
<ul><li>Partner closely with Clinical Affairs to support global clinical studies, including IDE, PMCF, registries, and post-market studies.</li>
<li>Provide regulatory guidance on protocol development, clinical study design, and regulatory approval pathways.</li>
<li>Support regulatory submissions associated with clinical trial approvals across multiple countries and regions.</li>
<li>Participate in investigator meetings, regulatory inspections, audits, and agency interactions.</li>
</ul>Agency Interactions &amp; Compliance
<ul><li>Represent the company during interactions with FDA, Notified Bodies, Ministries of Health, and other regulatory authorities.</li>
<li>Support preparation for regulatory inspections and audits.</li>
<li>Maintain awareness of evolving global regulatory requirements and communicate potential impacts to leadership.</li>
<li>Contribute to regulatory intelligence activities and long-term market expansion planning.</li>
</ul>Cross-Functional Leadership
<ul><li>Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&amp;D teams to ensure regulatory requirements are incorporated throughout the product lifecycle.</li>
<li>Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities.</li>
<li>Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.</li>
</ul>Qualifications &amp; Experience:
<ul><li>Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.</li>
<li>10+ years of Regulatory Affairs experience within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred.</li>
<li>Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA supplements.</li>
<li>Experience supporting clinical-stage medical device programs and global clinical studies.</li>
<li>Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and international regulatory frameworks.</li>
<li>Experience interacting directly with regulatory agencies, notified bodies, and international health authorities.</li>
<li>Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable.</li>
<li>Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development.</li>
<li>Excellent written, verbal, and presentation skills.</li>
<li>Ability to thrive in a fast-paced, entrepreneurial environment and work effectively across global teams.</li>
</ul>Preferred Qualifications:
<ul><li>Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies.</li>
<li>Prior experience supporting regulatory expansion into Europe, the Middle East, and emerging international markets.</li>
<li>Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.</li>
</ul>
<div></div><div><div>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.</div>
<div></div><div>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.</div></div></div>

Manager / Sr. Manager, Regulatory Affairs

Sandoz Egypt

<div>
 <ul>
 <li>
 Responsible for implementing regulatory strategy and managing operational activities for the assigned SSA countries.
 </li>
 <li>
 Responsible to coordinate and follow up with all responsible distributors and local representatives and scientific offices on the geographical region of SSA.
 </li>
 <li>
 Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for the assigned SSA countries.
 </li>
 <li>
 Find synergies between countries, align with different stakeholders to obtain approvals and unlock struggles with appointments and long timelines.
 </li>
 <li>
 Partners with regions align regulatory strategy in order to fulfil business objectives -Implements Regulatory Functional Plan across the assigned SSA countries.
 </li>
 <li>
 Determines requirements and sets objectives for Health Authority interactions .
 </li>
 <li>
 Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
 </li>
 <li>
 Develops and implements plans for timely response to Health Authority requests and coordinates responses.
 </li>
 <li>
 Drives coordination, planning, and submission of dossiers in the assigned SSA countries.
 </li>
 <li>
 Review of global dossier summary documents.
 </li>
 <li>
 Develops and implements plans to avoid/minimize clock stops during submission review.
 </li>
 <li>
 Responsible to maintain KPIs of all compliance and safety metrics from regulatory perspective.
 </li>
 <li>
 Responsible for facilitating timely submission and approval of dossier with Health Authority under the guidance of the global and regional RA
 </li>
 <li>
 Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.
 
 
 </li>
 </ul>
 
 Key Performance Indicators
 
 
 
 <ul>
 <li>
 Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
 </li>
 <li>
 Successful management of local distributors and scientific offices in countries and ensure KPI monitoring and stakeholder management.
 </li>
 <li>
 Identification of main Health Authority issues
 </li>
 <li>
 Participation in relevant regulatory Boards leading to valuable input from these Boards.
 </li>
 <li>
 Successful Participation in Health Authority interactions to achieve business objectives.
 </li>
 <li>
 Adherence to Sandoz policy and guidelines
 </li>
 <li>
 Project &amp; stakeholder feedback
 
 
 </li>
 </ul>
 
 Minimum Requirements
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy or related field
 </li>
 <li>
 7+ years of relevant regulatory experience with 3+ years in managerial role within pharmaceutical industry
 </li>
 <li>
 Experience in regulatory affairs in the region of SSA and working the distributors and country scientific offices.
 </li>
 <li>
 Excellent knowledge of local legislation requirements in the field of pharmaceutical registration
 </li>
 <li>
 Experience in interacting with government authorities
 </li>
 <li>
 Strong knowledge of labeling requirements and GxP documentations
 </li>
 <li>
 Attention to detail, organizational skills and ability to work with documentation
 </li>
 <li>
 Fluent in English and Arabic . French is a plus.
 </li>
 </ul>
</div>

Regulatory Affairs Senior Manager, Sub‑Saharan Africa

dLocal

<div>
 
 Why should you join dLocal?
 
 
 
 dLocal enables the biggest companies in the world to collect payments in 40 countries in emerging markets. Global brands rely on us to increase conversion rates and simplify payment expansion effortlessly. As both a payments processor and a merchant of record where we operate, we make it possible for our merchants to make inroads into the world&rsquo;s fastest-growing, emerging markets.
 
 
 By joining us you will be a part of an amazing global team that makes it all happen. Being a part of dLocal means working with 1000+ teammates from 30+ different nationalities and developing an international career that impacts millions of people&rsquo;s daily lives. We are builders, we never run from a challenge, we are customer-centric, and if this sounds like you, we know you will thrive in our team.
 
 
 
 What will I be doing?
 
 
 
 <ul>
 <li>
 Support license and registration applications across MENA jurisdictions (strategy, documentation, regulatory interactions) through to approval
 </li>
 <li>
 Maintain and update the licensing tracker of the application status, timelines
 </li>
 <li>
 Coordinate with external regulatory advisors and local law firms on license applications, structural questions, and regulatory perimeter assessments
 </li>
 <li>
 Contribute to dLocal's long-term licensing strategy for the region
 </li>
 <li>
 Maintain the regulatory framework by country and entity for day-to-day use: what licenses and permissions exist, what activities they authorise, applicable conditions, limits, and reporting obligations
 </li>
 <li>
 Ensure quality, accuracy, and timely delivery of regulatory reports and compliance submissions for each licensed MENA entity
 </li>
 <li>
 Identify and assess how regulatory requirements apply to new business needs (new flows, use cases, products), and design compliant operating models
 </li>
 <li>
 Provide expert advice to internal teams
 </li>
 <li>
 Support merchant and partner onboarding from a regulatory standpoint
 </li>
 <li>
 Monitor regulatory developments and trends across the region
 
 
 
 </li>
 </ul>
 
 What skills do I need?
 
 
 
 <ul>
 <li>
 Advanced degree in Law, Compliance, Finance, or a comparable field
 </li>
 <li>
 5+ years of experience in a regulatory affairs, compliance, or legal advisory role &mdash; ideally within a fintech, payments company, financial institution, or law firm operating in the MENA region
 </li>
 <li>
 Deep knowledge of financial services regulation across MENA markets, including payment institution licensing frameworks, AML/CFT requirements, and data privacy obligations
 </li>
 <li>
 Fluency in Arabic and English (written and spoken) is mandatory. French is a plus for Morocco-based candidates
 </li>
 <li>
 Proven ability to operate across both licensing (forward-looking, strategic) and compliance/assurance (operational, day-to-day) functions
 </li>
 <li>
 Experience managing regulatory relationships and submissions directly with MENA financial authorities
 </li>
 <li>
 Highly analytical, structured, and detail-oriented &mdash; able to translate complex regulatory requirements into practical business guidance
 </li>
 <li>
 Autonomous and hands-on, comfortable working in a fast-paced, international environment with multiple workstreams in parallel
 </li>
 <li>
 Professional and collaborative, with strong stakeholder management skills across diverse internal teams
 
 
 
 </li>
 </ul>
 
 What do we offer?
 
 
 
 Besides the tailored benefits we have for each country, dLocal will help you thrive and go that extra mile by offering you:
 
 
 <ul>
 <li>
 Flexibility: we have flexible schedules and we are driven by performance
 </li>
 <li>
 Fintech industry: work in a dynamic and ever-evolving environment, with plenty to build and boost your creativity
 </li>
 <li>
 Referral bonus program: our internal talents are the best recruiters - refer someone ideal for a role and get rewarded
 </li>
 <li>
 Social budget: you'll get a monthly budget to chill out with your team (in person or remotely) and deepen your connections!
 </li>
 <li>
 dLocal Houses: want to rent a house to spend one week anywhere in the world coworking with your team? We&rsquo;ve got your back!
 
 
 
 </li>
 </ul>
 
 Flexibility in how you work:
 
 We focus on impact and productivity over fixed hours. This means our teams have flexible schedules and, depending on your role and location, you will combine self‑managed focus time with moments of in‑person connection in our collaboration hubs.
 
 
 
 What happens after you apply?
 
 
 
 Our Talent Acquisition team is invested in creating the best candidate experience possible, so don&rsquo;t worry, you will definitely hear from us. We will review your CV and keep you posted by email at every step of the process!
 
 
 Also, you can check out our webpage, Linkedin and Youtube for more about dLocal!
 
 
 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
</div>

Regulatory Affairs Officer – MENA

Kraft Heinz

<div>
 The Kraft Heinz Company is looking for a Scientific and Regulatory Affairs Specialist who will support scientific and regulatory activities to help ensure products comply with applicable regulations and internal standards. This role will collaborate cross-functionally to review product formulations, ingredients, labeling, and claims; prepare and maintain regulatory documentation; monitor regulatory changes; and provide guidance to internal stakeholders throughout product development and commercialization. The ideal candidate has a strong foundation in food science and regulatory requirements, excellent attention to detail, and the ability to communicate clearly with partners across R&amp;D, Quality, Legal, and Commercial teams.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for providing timely compliance input to all projects and ensure it meets and aligns with food compliance related laws, legislation, and regulations across Africa &amp; Trade markets
 </li>
 <li>
 Responsible to give compliance guidance in work streams, and to follow up, verify and validate execution of such actions by stakeholders
 </li>
 <li>
 Accountable for validating that ingredients, formulas, labelling, and claims are in full compliance with laws and regulations in markets been sold
 </li>
 <li>
 Communicate anticipated issues and provide regulatory support and compliance guidance for projects handled to the relevant stakeholders and forums
 </li>
 <li>
 Support a proactive strategic approach in regulatory function to identify, monitor, analyze early signals of upcoming regulations that might have impact in A&amp;T market, categorize them as per their likelihood and potential impact for the business.
 </li>
 <li>
 Build and maintain relationships with the relevant industrial groups and authorities to maintain awareness of new food legislations.
 </li>
 <li>
 Track- monitor and report on the completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
 </li>
 <li>
 Drive cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products.
 </li>
 <li>
 Proactively identify and communicate SRA risk in any project or work stream
 </li>
 <li>
 Accountable to ensure risk assessment and mitigation plans are communicated to stakeholders
 </li>
 <li>
 Lead the registration process, collecting relevant documents, and keeping track of license expiration for the relevant SSA markets
 </li>
 <li>
 Drive a culture of scientific and regulatory affairs adherence to internal and external compliance processes and practices, driving continuous improvements opportunities
 </li>
 <li>
 Provide technical and legal labelling Information and support artwork approval process
 </li>
 <li>
 Ensure consistency and synergy in label &amp; declarations on packaging across A&amp;T markets (especially shared artworks)
 </li>
 <li>
 Scientific and regulatory affairs representation in all projects driven forums
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Biotechnology, or Food Science
 </li>
 <li>
 5 years of experience in regulatory compliance/affairs preferably within a food, beverage, or consumer sector
 </li>
 <li>
 Experience working with Microsoft programs and system tools related to recipes and artworks
 </li>
 <li>
 Experience in translation is preferred
 </li>
 <li>
 Fluent in Arabic &amp; English, French is a plus
 </li>
 </ul>
</div>

Scientific & Regulatory Affairs Specialist – Africa & Trading

Expertise Recruitment

<div><div>POSITION OVERVIEW 
<div>We are seeking a commercially driven and strategically minded Sales &amp; Marketing Manager with a strong pharmaceutical background and proven experience working within multinational companies (MNCs). Based in the UAE and covering the local market with potential GCC exposure, this senior-level role is responsible for leading the full commercial function &mdash; from field force management and brand strategy to key account development and regulatory engagement. The ideal candidate brings deep knowledge of the UAE pharmaceutical landscape, established relationships with healthcare stakeholders, and the agility to operate within a multinational corporate framework. 
</div><div> 
KEY RESPONSIBILITIES 
</div>Sales Leadership &amp; Revenue Growth<ul><li> 
 Develop and execute the annual commercial strategy and sales business plan aligned with company targets</li><li> 
 Lead, coach, and manage a team of medical representatives, product specialists, and sales executives across UAE territories</li><li> 
 Set and track individual and team sales targets, KPIs, and performance metrics with regular reviews</li><li> 
 Drive revenue growth across hospital, retail pharmacy, institutional, and specialty clinic channels</li><li> 
 Manage and grow key accounts including MOH-listed hospitals, private hospital groups, pharmacy chains (Aster, Life Pharmacy, BinSina, Supercare), and group purchasing organizations</li><li> 
 Negotiate and close distribution agreements, tenders, and commercial contracts with trade partners and government entities</li><li> 
 Oversee UAE government and semi-government hospital tender submissions and formulary listings</li></ul> 
Marketing &amp; Brand Management<ul><li> 
 Design and implement brand strategies and go-to-market plans for new and existing pharmaceutical products in the UAE</li><li> 
 Develop and localize promotional campaigns, detailing materials, and multi-channel marketing content compliant with UAE regulations</li><li> 
 Conduct market research, competitive analysis, and HCP insights to identify opportunities and inform strategy</li><li> 
 Collaborate with regional and global marketing teams (within the MNC structure) to adapt international campaigns to the UAE market</li><li> 
 Manage the marketing budget, track ROI on all promotional activities, and present spend reports to senior leadership</li><li> 
 Organize and lead CME events, product launch symposia, KOL advisory boards, and HCP engagement programs</li><li> 
 Oversee digital marketing activities including email campaigns, medical platform presence (Veeva, CLM), and social/scientific channels</li></ul> 
Market Access &amp; Government Affairs<ul><li> 
 Drive formulary inclusions and product listings across MOH, DHA, DOH, and SEHA/DAMAN networks</li><li> 
 Manage relationships with MoHAP Pricing Committee, DHA, and relevant regulatory bodies to support reimbursement objectives</li><li> 
 Engage with insurance providers and TPAs (Daman, Neuron, NAS, AXA Gulf) to support coverage and reimbursement for key products</li><li> 
 Lead pricing strategy in line with MoHAP price-control regulations and tender requirements</li><li> 
 Support product registration, renewals, and regulatory submissions in coordination with the regulatory affairs team</li></ul> 
Key Opinion Leader (KOL) &amp; Stakeholder Engagement<ul><li> 
 Build, maintain, and grow a national network of KOLs across relevant therapeutic areas</li><li> 
 Develop and execute structured KOL engagement plans including advisory boards, speaker programs, and congress sponsorships</li><li> 
 Represent the company at UAE and regional medical congresses, trade exhibitions, and industry forums</li><li> 
 Build strong relationships with hospital department heads, pharmacy directors, and procurement officers</li></ul> 
Business Development<ul><li> 
 Identify new market opportunities, unmet needs, and potential product gaps in the UAE pharma landscape</li><li> 
 Support evaluation and due diligence for potential in-licensing, co-promotion, or distribution partnership deals</li><li> 
 Monitor competitor activities, pricing dynamics, and pipeline developments; deliver actionable commercial insights</li><li> 
 Collaborate with supply chain and logistics teams to ensure product availability, forecasting accuracy, and inventory management</li></ul> 
Reporting &amp; Cross-Functional Collaboration<ul><li> 
 Prepare monthly, quarterly, and annual performance dashboards and business reviews for regional and global management</li><li> 
 Work seamlessly across medical affairs, regulatory, supply chain, finance, and HR functions within the UAE team</li><li> 
 Represent UAE commercial interests in GCC and global commercial planning cycles and brand team meetings</li><li> 
 Manage and ensure full compliance with IFPMA, local UAE codes of conduct, and company SOPs</li></ul></div></div><div></div>

Sales & Marketing Manager

Sandoz

Major accountabilities: 
<ul>
<li>Receive and implement scientific data from Regulatory Affairs, New Products, or Export departments into artwork designs.</li>
<li>Prepare packaging artwork (outer cartons, leaflets, inner/outer labels) in line with production specifications.</li>
<li>Lead discussion with relevant functions to check and approve the artwork before submitting on the system.</li>
<li>Submit artwork to Regulatory Affairs for review on the relevant artwork management systems</li>
<li>Apply required amendments and resubmit artwork for review.</li>
<li>Prepare medical leaflets in alignment with the approved Word files from the regulatory affairs team.</li>
<li>Develop internal forms and maintain local archive of all artworks with relevant change history.</li>
<li>Coordinate with the Supply Chain department regarding packaging material codes.</li>
<li>Manage the artwork management systems</li>
<li>Follow up with Quality Control and Export departments on the review of supplier proofs.</li>
<li>Ensure compliance with company SOPs and regulatory standards for artwork processes.</li>
</ul>
Key performance indicators: 
<ul>
<li>Quick and accurate design of artworks according to received requests.</li>
<li>Accuracy and compliance of artwork with regulatory and quality standards.</li>
<li>Timely implementation of amendments.</li>
<li>Effective coordination with internal departments and suppliers.</li>
<li>Satisfaction of stakeholders with the quality of delivered artwork.</li>
</ul>
What you’ll bring to the role: 
<ul>
<li>Bachelor’s degree in Applied Arts, Graphic Design, or related field.</li>
<li>Proficiency in design software (Adobe Illustrator, Photoshop, InDesign).</li>
<li>Experience and knowledge in artwork management systems like SAP , loftware or similar.</li>
<li>3 to 5 years practical experience in artwork and packaging design (preferably in the pharmaceutical industry).</li>
<li>Good knowledge of regulations and artwork submission processes.</li>
<li>Strong language skills in English.</li>
<li>Strong communication and coordination skills.</li>
<li>High attention to detail and ability to meet deadlines.</li>
</ul>
Languages: 
<ul>
<li>English.</li>
</ul>
Why Sandoz?
 
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
 
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
 
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
 
Join us!
 
Commitment to Diversity& Inclusion: 
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
 
#Sandoz

Regulatory Affairs Artwork Associate

AbbVie

<div>Company Description 
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.
Responsibilities:<ul><li>
Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie&rsquo;s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.</li><li>
Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.</li><li>
Summarizes findings, under supervision, in concise reports for distribution within AbbVie</li><li>
Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.</li><li>
Development and guides implementation strategies for promotional activities</li><li>
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.</li><li>
Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members</li><li>
Effectively presents pertinent information to appropriate cross-functional groups.</li><li>
Effectively delivers difficult messages to commercial organizations without damage to relationships</li><li>
Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.</li><li>
This role will work a hybrid work schedule (3 days in office &amp; 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA; Washington, D.C.; or Rockville, MD.</li></ul>
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required 
Qualifications 
<ul><li>
Minimum: Bachelor&rsquo;s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)</li><li>
Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)</li><li>
Experience working in a complex and matrix environment and exhibits strong negotiation skills</li><li>
Strong communication skills, both oral and written</li><li>
Experience in management capacity preferred</li><li>
Experience in US Regulatory Affairs Advertising and Promotion</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our long-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.
<div></div>AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology

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