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Senior Manager Regulatory Affairs

  1. London
Central London
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
34339
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Senior Manager Regulatory Affairs - Remote, UK - 12-Months 

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Manager Regulatory Affairs. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.


Responsibilities: 
  • Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
  • With minimal 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 labelling, 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.
  • 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).
  • Working with policies, procedures and SOP’s.

 Requirements: 
  • Knowledge of Regulatory principles.
  • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
  • Good knowledge of national legislation and regulations relating to medicinal products.
  • Awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
  • Knowledge and experience in the local regulatory environment relevant for product area and development stage.
  • Understanding of drug development.
  • Able to anticipate regulatory Agency questions and potential response.

If this role is of interest to you, please apply now! 

 #LI-KT1
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