Regulatory Affairs Manager
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
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.
Live
What you will do
Let’s do this. Let’s change the world. In this vital role, you will play a key part in shaping and executing regulatory strategies that support Amgen’s portfolio across the Gulf markets.
Role
The Regulatory Affairs Manager is assigned to products across Gulf (5 markets), plans and executes regulatory strategies for products with medium-complexity programs and medium business impact in the assigned country(ies). The role aligns local regulatory requirements with corporate standards, manages compliant and timely submissions, maintains product labeling and regulatory compliance, and serves as a point of contact with Health Authorities.
Key responsibilities and accountabilities
Contribute to the local filing plan for Marketing Authorizations and lifecycle maintenance, advising and aligning with the local cross-functional team.
With general supervision, execute the filing plan for the assigned country(ies), ensuring submissions are made on time and meet corporate and local regulatory requirements.
Provide local regulatory input to product strategies and advise on local mechanisms that may optimize product development and regulatory approvals.
Review and approve promotional and non-promotional materials in accordance with applicable procedures and local requirements.
Review Patient Support Programs from a regulatory perspective and provide guidance to support compliance with applicable local requirements and company procedures.
Review digital health and software solutions from a regulatory perspective, including assessment of applicable local requirements and regulatory implications.
Gather, assess, and communicate competitive regulatory intelligence relevant to assigned products, therapeutic areas, and markets.
Assess and apply reliance pathways, where applicable, and support the use of Accumulus for relevant regulatory collaboration and submission activities.
Own and maintain the quality, completeness, accuracy, and timeliness of regulatory data in designated systems and tools, including Veeva RIM, the CPP tool, and regulatory intelligence databases.
Prepare clear and concise presentations, as requested, on new or updated regulations, regulatory guidelines, and pricing intelligence, highlighting relevant implications, risks, opportunities, and recommended actions for internal stakeholders.
Monitor the external regulatory environment, distributor management, trade association developments, national legislation, regulatory policy, and technical guidance; assess and communicate potential impact to relevant local and regional stakeholders.
Perform regulatory research to identify relevant histories, precedents, and information that support product development, registration, and lifecycle decisions.
Health Authority interactions
Act as a point of contact with regulatory agencies in fulfilling local obligations.
Participate in and contribute to the preparation and conduct of local Health Authority interactions.
Ways of working and collaboration
Work closely with cross-functional colleagues in the country, affiliate, or hub to align on strategy and deliver regulatory and business goals.
Exchange regulatory information and intelligence with regulatory colleagues and cross-functional teams, providing timely advice on local regulatory considerations.
Partner with International Regulatory Leads and Global Regulatory Leads to support development, registration, and lifecycle management of assigned products.
Partner with peers to support consistent application of procedures and ways of working.
Establish regular contacts and interactions with distributors, where applicable.
Provide subject-matter expertise to process improvement projects and initiatives.
Participate in local regulatory process improvements, initiatives, and training.
Mentor and advise Local Regulatory Representatives at more junior levels.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs Manager we seek is an adaptable and engaged professional who thrives in a dynamic environment and is motivated by making a meaningful contribution to patients and the business. You will bring curiosity, sound judgment, and a solution-oriented mindset, while demonstrating the confidence and agility needed to contribute effectively in a fast-evolving organization.
Key interfaces
Local cross-functional teams
International Regulatory Leads and Global Regulatory Leads
Health Authorities and agency staff
Safety/Pharmacovigilance, Quality Assurance, Healthcare Compliance, Medical, and Commercial teams
Distributors, external vendors, and contractors, as applicable
Knowledge and skills
Knowledge of regulatory principles, policies, procedures, and standard operating procedures.
Comprehensive understanding of regulatory activities and how they affect other projects and processes.
Knowledge of national legislation and regulations relating to medicinal products.
Awareness of local registration procedures and challenges for Clinical Trial Applications, Marketing Authorizations, and lifecycle management activities.
Knowledge and experience in the regulatory environment relevant to the assigned product area and development stage.
Understanding of drug development and ability to understand and communicate scientific and clinical information.
Strong teamwork, written and oral communication, negotiation, and influencing skills.
Ability to resolve conflicts and develop practical courses of action that support beneficial outcomes.
Cultural awareness and sensitivity to achieve results across country, regional, and international boundaries.
Ability to exercise sound judgment, making informed regulatory recommendations with general supervision
Demonstrate ownership, accountability, proactive issue management, supporting timely, compliant and business relevant regulatory outcomes
Qualifications and experience
Bachelor’s degree in pharmacy or related life sciences (required); advanced degree is an advantage
Typically, 4-8+ years of Regulatory Affairs experience with strong hands-on new product registration and lifecycle management.
In-depth knowledge of the Gulf (UAE, Kuwait, Qatar, Oman and Bahrain) legislation and regulations relating to medicinal products is preferred (biologicals, small molecules and biosimilars).
Demonstrated proficiency working in regulated document and workflow systems (e.g., Veeva Vault, RIM tools) and in cross-functional matrix environments.
Skills/behaviors: detail orientation, planning/priority management, proactive risk management, clear written/oral communication, cultural awareness, and a quality mindset.
Thrive
What you can expect of us
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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
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