Regulatory Affairs Manager

HOW MIGHT YOU DEFY IMAGINATION

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets change the this vital role you will play a key part in shaping and executing regulatory strategies that support Amgens 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

• Bachelors degree in pharmacy or related life sciences (required); advanced degree is an advantage

• Typically 48 years of Regulatory Affairs experience with strong handson 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 crossfunctional 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.

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.