associate director regulatory affairs

Amgen

Associate Regulatory Affairs - based in Dubai <p>Join to apply for the <b>Associate Regulatory Affairs - based in Dubai</b> role at <b>Amgen</b>.</p><p>You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.</p> What You Will Do <p>Let's do this. Let's change the world. In this vital role, you will manage country specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance:</p><ul><li>Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements</li><li>Reviews promotional and non promotional materials.</li><li>Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</li><li>Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You <p>We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.</p> Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>Understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Understanding of drug development.</li><li>Demonstrate ability to work in teams.</li><li>Ability to understand and communicate scientific/clinical information.</li></ul> Preferred Qualifications <ul><li>Regulatory experience of the Gulf Markets.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> What You Can Expect Of Us <p>As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><p>Apply now at </p><p>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>

Associate Regulatory Affairs - based in Dubai

Allmed Solutions

<p>We are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team. The Assistant Manager &ndash; Regulatory Affairs will play a key role in managing regulatory activities related to medical devices, ensuring full compliance with local and international regulatory standards.</p><p><b>Key Responsibilities:</b></p><ul><li>Develop and implement effective regulatory strategies to support product approvals.</li><li>Manage product registration processes and prepare regulatory documentation.</li><li>Ensure compliance with applicable regulatory requirements and standards.</li><li>Liaise with regulatory authorities for submissions, queries, and approvals.</li><li>Maintain regulatory compliance throughout the entire product lifecycle.</li><li>Provide regulatory guidance and updates to cross-functional teams.</li></ul><p><b>Requirements:</b></p><ul><li><b>Doctor of Pharmacy (Pharm-D)</b> degree.</li><li><b>1&ndash;3 years</b> of experience in Regulatory Affairs, preferably within the <b>medical devices industry</b>.</li><li>Strong communication, documentation, and analytical skills.</li><li>Ability to multitask, prioritize workloads, and meet tight deadlines in a fast-paced environment.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs60,000.00 - Rs150,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory Affairs

AECOM

<p></p><div><div><div><h2 class="jobSectionHeader"><b>Company Description</b></h2></div><div><p><b>
Work with Us. Change the World.</b></p><p>
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world&rsquo;s most complex challenges and build legacies for future generations.</p><p>
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.</p><p>
We're one global team driven by our common purpose to deliver a better world. Join us.</p></div></div><p></p><div><div><h2 class="jobSectionHeader"><b>
Job Description</b></h2></div><div><p>
AECOM are currently seeking an Associate Director to join our Advisory team in the sub-practice area of P3 Technical Advisory.</p><p>
Other sub-practice areas within our Advisory business includes Asset, Project Monitoring, Risk Management, Program, Strategy+, Procurement + Contracts and Construction Business Intelligence services, allowing the successful candidate to collaborate across our Advisory team and advise our clients across a wide range of built asset and infrastructure projects.</p><p>
We are looking for highly motivated applicants who possess specific knowledge and experience in this sub-practice area in addition to outstanding analytical, communication and creative skills. The successful candidate will report to our Advisory Lead for the Middle East with responsibility to lead, develop and grow our P3 Technical Advisory sub-practice in the delivery of services across the region, identify and secure of new sources of work, develop client relationships and lead client engagement in the UAE, KSA, Qatar and Bahrain markets.</p><p><b>
Experience and Qualifications</b></p><ul><li>
Minimum 15 years relevant post education experience.</li><li>
Bachelor&rsquo;s degree in engineering / construction management / project management or equivalent.</li></ul><p><b>
Outline of Duties</b></p><ul><li>
Lead, develop and grow our P3 Technical Advisory sub-practice in the delivery of services across the region, identify and secure of new sources of work, develop client relationships and lead client engagement in the UAE, KSA, Qatar and Bahrain markets.</li><li>
Liaising with client and other stakeholders.</li><li>
Manages the resources with the team, all within the established budgets.</li><li>
Leads proposals and bids for opportunities.</li><li>
Raising the company and professional profile by as an industry leader and / or thought leader.</li><li>
Accountable for a variety of complex deliverables throughout the lifecycle of multiple projects.</li><li>
Ensuring the client receives the assistance needed to implement the recommendations / solutions.</li><li>
Technical report writing in accordance with international standards.</li><li>
Preparing and facilitating workshops.</li><li>
Carrying out research and data collection.</li><li>
Conducting problem solving analysis and technical analysis of data gathered.</li><li>
Preparing and presenting recommendation papers, reports, process; procedure and system manuals.</li><li>
Formulating and implementing recommendations \ solutions.</li><li>
Interprets data and presents to clients.</li><li>
Presents project deliverables to clients.</li></ul><p><b>
Technical Skills Range</b></p><p>
Candidates will be expected to possess skills in the following core areas:</p><ul><li>
Knowledge and experience in the delivery of P3 technical services in the region.</li><li>
Demonstrate an understanding and ability to work with other advisors associated with projects.</li></ul><p>
Candidates will also be expected to possess skills in one or more of the following:</p><ul><li>
Proficiency in Microsoft Office Suite.</li><li>
Project management, project work planning, scheduling and resource deployment.</li></ul><p><b>
Culture and Personality</b></p><p>
Candidates will be expected to possess as many of these attributes as possible:</p><ul><li>
Highly collaborative, highly communicative and highly creative.</li><li>
Excellent oral, written and visual communication skills.</li><li>
Comfortable in a fast-paced, open and creative environment.</li><li>
Ability to lead workshops, focus groups and presentations.</li><li>
Familiarity with research methodologies and processes.</li><li>
High degree of flexibility and agility.</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b>
Qualifications</b></h2></div><div><ul><li>
Bachelor&rsquo;s and Master&rsquo;s degree and professional qualifications in one or more of business, economics, architecture, planning, design, social science or engineering</li><li>
Minimum 15 years relevant post education experience in design, business consulting</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b>
Additional Information</b></h2></div><div></div><div><p><b>
About AECOM</b></p><p>
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&amp;D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.</p><p>
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients&rsquo; complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle &ndash; from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2024. Learn more at aecom.com.</p><p><b>
What makes AECOM a great place to work</b></p><p>
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you&rsquo;ll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you&rsquo;ve always envisioned. Here, you&rsquo;ll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.</p><p>
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.</p></div></div></div>

Associate Director - Advisory

Qiddiya | القدية

<div>
 <strong>
  Qiddiya is Saudi Arabia's future capital of entertainment, sports, and culture &mdash; a 360 km&sup2; mega-project just outside Riyadh. From F1-grade racetracks and theme parks to stadiums and performance venues, we're creating a destination like no other. This is more than a project, it's a national transformation. As construction accelerates, we're hiring ambitious talent to help shape it. If you're driven by scale, impact, and the chance to build something iconic from the ground up, Qiddiya is calling for you.
  <br/>
  <br/>
 </strong>
 <strong>
  General Summary:
  <br/>
  <br/>
 </strong>
 The Regulatory &amp; Policy team within the Transport Business Unit (TBU) plays a vital role in shaping the transport agenda at Qiddiya by ensuring alignment with national regulatory frameworks, policy environments, and sector-specific mandates. The team leads on regulatory submissions, inter-governmental engagement, policy impact assessments, and supports the TBU's compliance with external approvals and governance protocols. Working cross-functionally, the team serves as the BU's interface with external regulators, government bodies, and internal delivery stakeholders.
 <br/>
 <br/>
 The Senior Manager supports the execution of the TBU's regulatory roadmap, manages key relationships with government agencies, and leads the preparation of critical regulatory submissions and position papers. The role ensures that regulatory timelines are met and that Qiddiya's interests are well-represented in external engagements.
 <br/>
 <br/>
 <strong>
  Essential Duties and Responsibilities:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Support the Associate Director in managing approvals and permits from regulatory authorities
  </li>
  <li>
   Coordinate development of regulatory documents and responses to government inquiries
  </li>
  <li>
   Track and report on regulatory changes impacting transport projects
  </li>
  <li>
   Build working relationships with government officials and regulatory entities
  </li>
  <li>
   Support internal project teams with regulatory guidance and interface planning
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Requirements
  <br/>
  <br/>
 </strong>
 <strong>
  Qualifications:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor's degree in Public Policy, Law, Political Science, Transport Planning, or related discipline
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Years of Experience:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   8+ years in regulatory affairs, permitting, or policy advisory in a transport or infrastructure setting
  </li>
 </ul>
</div>


Senior Manager - Regulatory and Policy (CDU3) - CDUP 2064

Ferring Pharmaceuticals, Inc.

<div><div>Job Description:</div><div>
Regulatory Affairs Associate</div><div></div><div>
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women&rsquo;s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.</div><div>
Joining our Regulatory team, you will be part of an empowering and collaborative culture where your work plays a key role in ensuring patient safety, regulatory compliance and sustainable access to medicines. By working closely with cross-functional teams and external stakeholders, you will support regulatory excellence, life-cycle management and the consistent maintenance of our portfolio. Your contribution helps ensure that high-quality therapies remain available, compliant and trusted throughout their entire life cycle.</div><div></div><div>
Ferring+You</div><div></div><div>
We are looking for a Regulatory Affairs Associate to join our team and take a key role in regulatory compliance, quality assurance, document governance, and cross-functional business support in line with local regulations and global procedures, reporting directly to the Regulatory Affairs Manager.</div><div></div><div>
Your day at Ferring</div><ul><li><div>
Act as Document Accountable Person (DAP) and Document Controller (DC), ensuring document lifecycle management, consistency, and compliance</div></li><li><div>
Serve as the main local regulatory contact and manage regulatory compliance activities</div></li><li><div>
Coordinate new drug approvals, including dossier preparation, submissions, and follow-up with local Health Authorities</div></li><li><div>
Manage regulatory submissions, variations, renewals, and product lifecycle activities</div></li><li><div>
Support and coordinate regulatory inspections and maintain validity of licenses and certificates</div></li><li><div>
Monitor regulatory intelligence, assess impact, and proactively communicate regulatory changes</div></li><li><div>
Ensure timely and accurate updates in global and local regulatory systems (e-CTD, Veeva Vault, Track Wise, etc.)</div></li><li><div>
Prepare, review, and approve artworks and labeling to support submissions and product launches</div></li><li><div>
Review promotional and non-promotional materials in line with local regulations and global procedures</div></li><li><div>
Support Quality Management System (QMS) implementation and sustainability, including local market release</div></li><li><div>
Support regulatory and pricing applications, including document coordination and pricing data monitoring</div></li></ul><div></div><div>
Behind our collaboration&hellip;There&rsquo;s you</div><ul><li><div>
University degree in Pharmacy</div></li><li><div>
Min. 2-3 years of practical experience in regulatory and quality assurance</div></li><li><div>
Know-how of interactions with regulatory authorities</div></li><li><div>
Experience with e-CTD, Veeva Vault, Track Wise, and pricing is a plus</div></li><li><div>
Eager to learn personality, team player approach, attention to details</div></li><li><div>
Fluent in English language (written and verbal)</div></li></ul><div></div><div>
People come first at Ferring</div><div></div><ul><li><div>
Get inspired from our commitment to advocate for everyone&rsquo;s right to build a family, no matter who you are, where you live or who you love</div></li><li><div>
Our inclusive support package &ndash; &ldquo;Building Families at Ferring&rdquo; provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role</div></li><li><div>
Parental leave for both birthing and non-birthing parents</div></li><li><div>
Extended support on family building journey</div></li></ul><div></div><div>
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member&rsquo;s contributions. Imagine the power of your career when it&rsquo;s Ferring + You.</div><div></div><div>
Behind our purpose&hellip; There&rsquo;s you</div><div>
If our mission and your vision are aligned, please apply.</div><div>
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.</div><div></div><div>
Location:</div>
Ferring Turkey</div>

Regulatory Affairs Associate

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $70,000 - $80,000</li>
</ul><div><i>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<p>
Reporting directly to the Associate Director of Regulatory Science (the &quot;Associate Director&quot;) of the Clinical Trials Office (the &quot;CTO&quot;) of Columbia University's Vagelos College of Physicians &amp; Surgeons (&quot;P&amp;S&quot;) at Columbia University Irving Medical Center (&quot;CUIMC&quot;), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials.</p>
<p>
The CTO, which is operated jointly with the New York-Presbyterian Hospital (&quot;NYPH&quot;) assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research.</p>
<p></p>
<p>Responsibilities</p>
<p>
The Regulatory Science Specialist is responsible for the following:</p>
<ul>
<li>Collaborates with the Associate Director, the Executive Director of the CTO (the &quot;Director&quot;), the Medical Director of the CTO, CUIMC faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals.</li>
<li>Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission.</li>
<li>Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials.</li>
<li>Assists in the implementation of a training program for research personnel, including research newsletters, workshops, and didactic training sessions upon request.</li>
<li>Provides guidance regarding regulatory and institutional requirements to investigators and research personnel</li>
<li>Provides assistance and support in creating and maintaining www.ClinicalTrials.gov records in compliance with applicable regulations and policies.</li>
<li>Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials.</li>
<li>Collaborates with the CTSA and the HRPO/IRB in developing programs such as programs to increase patient recruitment and to address regulatory and compliance needs.</li>
<li>Provides support of RecruitMe Platform for the CUIMC research community including:</li>
<li>Coordinating with investigators and research teams in RecruitMe entry.</li>
<li>Developing training and process improvement projects, and other project management duties with RecruitMe.</li>
<li>Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites.</li>
<li>Fulfilling reporting requirements for management, including metrics from Google Analytics data.</li>
<li>Monitoring external communications for social media websites.</li>
<li>Liaising with RecruitMe contacts, information technology (&quot;IT&quot;) groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites.</li>
Represents the Manager and Director in his/her absence and all other duties as assigned.<br>
<li>
</li>
</ul><p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor's degree</li>
<li>At least 4 years of experience in conducting clinical research</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<ul>
<li>In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:</li>
<li>Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs</li>
<li>Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research</li>
<li>Demonstrable ability to collaborate with partners in research, investigators and coordinators</li>
<li>Excellent verbal and written communication skills</li>
<li>Excellent interpersonal and presentation skills</li>
<li>Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office</li>
Ability to manage/handle multiple tasks, teams, and teamwork simultaneously.<br>
<li>
</li>
</ul><p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Regulatory Science Specialist

Brillio LLC

<div><h1 class="jobSectionHeader"><b>Associate Director, Strategy &amp; Consulting - R01556900</b></h1>
<p></p><div><b>Associate Director, Strategy &amp; Consulting</b></div><h6 class="jobSectionHeader"><b>
Primary Skills</b></h6><ul><li>
Product roadmap and vision, Design product blueprint, Business Processes at program/enterprise level, Manage Product Backlog, Stakeholder Management
</li></ul><h6 class="jobSectionHeader"><b>Specialization</b></h6><ul><li>
Product Management: Associate Director, Strategy &amp; Consulting
</li></ul><h6 class="jobSectionHeader"><b>Job requirements</b></h6><ul><li><b>
Role Overview</b></li><li>
We are hiring a <b>Consulting Lead &ndash; Product Management (PBM / Pharmacy Domain)</b> to support and scale our growing <b>PBM and pharmacy initiatives</b> in <b>Hyderabad</b>. This role will lead strategic product consulting engagements, drive product excellence, and mentor high-performing product teams while partnering closely with clients and cross-functional stakeholders.</li></ul><div></div><ul><li><b><br>
Key Responsibilities:</b></li></ul><br>
<div></div><ul><li>
Lead <b>product consulting engagements</b> across <b>PBM and pharmacy</b> verticals</li><li>
Manage, mentor, and coach a <b>high-performing team of product managers</b></li><li>
Partner with clients and internal cross-functional teams to define <b>product strategy, vision, and roadmap</b></li><li>
Standardize <b>product management processes, artifacts, and delivery metrics</b> across engagements</li><li>
Drive innovation through <b>domain research, industry benchmarking, and emerging technologies</b> in pharmacy and PBM</li><li>
Act as an <b>executive sponsor</b> for strategic initiatives and major product releases</li><li>
Ensure alignment between <b>business objectives, regulatory requirements, and product outcomes</b></li></ul><div></div><ul><li><b><br>
Qualifications &amp; Experience</b></li></ul><br>
<div></div><ul><li>
Proven experience working on <b>pharmacy and/or PBM products</b>, with <b>client-facing consulting exposure</b></li><li>
Strong <b>people leadership</b> and team management capabilities</li><li>
Excellent <b>communication, facilitation, and stakeholder management</b> skills</li><li>
Exposure to the <b>U.S. healthcare market</b> and understanding of relevant <b>regulatory trends</b> (preferred)</li><li>
Ability to operate in a fast-paced, multi-stakeholder environment and drive outcomes</li></ul></div><p></p>

Associate Director, Strategy & Consulting – R01556900

Search 10000+ Associate director regulatory affairs jobs near you this January. New roles added regularly across leading industries. Apply today.