Senior Associate Regulatory Affairs (Based in Johannesburg)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Local Regulatory Representative (LRR), Sr Associate

WHAT YOU WILL DO

Group Purpose

Local Regulatory Affairs provides South Africa regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen portfolio in South Africa & Sub Sahara Africa

Job Summary

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support an LRR or lead the planning and execution of regulatory strategies for a program(s) under the supervision of an experienced Local Regulatory Lead. In addition, the LRR South Africa serves as the regional regulatory intelligence focal point for Sub-Saharan Africa (SSA), supporting proactive monitoring, assessment, communication, and governance of regulatory developments across SSA markets to enable strategic planning, market expansion, and launch readiness.

The role partners with Global Regulatory Affairs, Regulatory Policy, International Regulatory Leads (IRLs), distributors, and local stakeholders to identify emerging regulatory trends, assess business impact and regulatory risk, and support regulatory feasibility assessments for new market entry opportunities across SSA (Sub Sahara Africa) .

• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
• Act as the point of contact with regulatory agencies.
• Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc.

Key Activities

Strategic and Execution

• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• With close supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
• Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text.
• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
• Reviews and approves the promotional and non-promotional materials.
• Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
• Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
• Participates in the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
• Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives

HEALTH AUTHORITY INTERACTIONS

• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Participates/contributes to local agency interactions and their preparation.

COMMUNICATION AND COLLABORATION

• Works closely with cross-functional colleagues in the country, Affiliate or Hub to align on strategy and deliver country/Affiliate/Hub goals.
• 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.
• Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
• Partners with peers to ensure consistency on procedures.
• Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).
• Establishes regular contacts and interactions with Distributors (if applicable).
• Provide SME support to process improvement projects/initiatives.

COUNTRY SPECIFIC ACTIVITIES

• Assists locally in Healthcare Compliance activities where applicable.
• Participates in local regulatory process improvements, initiatives, and training.
• Oversees external vendor/contractor relationships where applicable.

REGULATORY RESEARCH

• Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement

REGULATORY INTELLIGENCE & SSA SUPPORT

• Owns the collection, validation, and dissemination of regulatory intelligence across SSA markets, including health authority publications, regulatory reforms, reliance pathway developments, pricing changes, localization policies, and emerging regulatory requirements.
• Assesses the business impact and regulatory risk associated with new regulations and communicates recommendations to MEA Regulatory Affairs leadership and relevant cross-functional stakeholders.
• Maintains SSA country intelligence databases, country regulatory profiles, and filing insights repositories, ensuring data quality, completeness, and timely updates.
• Acts as the primary liaison with Global Regulatory Intelligence teams and supports implementation of enterprise intelligence tools, governance processes, and data stewardship standards.
• Provides regulatory guidance for distributor-managed SSA markets and supports market expansion assessments, product launch readiness, and regulatory feasibility evaluations for new market opportunities.
• Identifies opportunities for accelerated pathways, reliance mechanisms, collaborative review procedures, and harmonization initiatives within Africa to support efficient regulatory planning.
• Builds and maintains relationships with key regulatory authorities, regional regulatory networks, industry associations, and regulatory forums where appropriate, and supports advocacy strategies aligned with regulatory policy priorities across Africa.
• Ensures lessons learned from submissions, approvals, RTQs, inspections, and agency interactions are captured, shared, and embedded into SSA regulatory intelligence records and future planning.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• Understanding of drug development.
• Demonstrate ability to work in teams.
• Ability to understand and communicate scientific/clinical information.

Education & Experience (Basic):

Master’s degree (scientific area) OR
Bachelor’s degree (scientific area) and 2 years of directly related experience.

Education & Experience (Preferred):

• In-depth regulatory experience in the applicable country(ies).
• In-depth knowledge of country(ies) legislation and regulations relating to medicinal products.

BE PART OF OUR TEAM

You would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

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.