Regulatory Affairs Manager
18 days ago
Cambridge
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. ork within the UK for at least the next 12 months.