PE Global is currently recruiting for a Regulatory Affairs Manager for a 12 month contract role with a leading multinational Pharma client based in Cambridge.
Hybrid – only once a month in the office.
Note: references to “local” in this job description may describe work with multiple markets or a centralized health authority/procedure for multiple markets. This includes the EU Regulatory Leads (EURLs) working with the European Medicines Agency (EMA) for the EU markets.
Job Responsibilities
- 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 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).
- Manages the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
For LRRs in Key Markets (KMRLs), the LRR is also responsible for:
- Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives
- As part of the Global Regulatory Team (GRT), provides regulatory direction/expertise on local regulatory mechanisms to optimize product development (eg, expediting studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and paediatric plans).
- 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 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.
Interested candidates should submit an updated CV.
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UKork within the UK for at least the next 12 months.
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