Provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.
- 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.
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Act as the point of contact with regulatory agencies.
- Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
- With general supervision, executes the filing plan (MA and Lifecycle maintenance) for the country, 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).
- Acts as the point of contact with regulatory agencies in fulfilling local obligations.
- Participates/contributes to local agency interactions and their preparation.
- Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver 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 Regional Regulatory Leads (RRLs) 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).
- Assists locally in Healthcare Compliance activities where applicable.
- Participates in local regulatory process improvements, initiatives and training.
- Oversees external vendor/contractor relationships where applicable.
- Assists locally in Healthcare Compliance, QA or pharma covigilance activities where applicable.
