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Regulatory Affairs Manager

  1. Remote
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
15-11-2023
32689
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Regulatory Affairs Manager – Remote – Life Sciences

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Regulatory Affairs Manager. 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 include:
  • 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 the 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 to the client.
  • 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).
Requirements
  • Knowledge of Regulatory principles.
  • Working with policies, procedures and SOP’s.
  • 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.
  • Good negotiation and Influencing skills.
  • Ability to anticipate and prevent potential issues.
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
  • Degree and in-depth regulatory experience and/or related to the country(ies).
  • Depth knowledge of country(ies) legislation and regulations relating to medicinal products.
If this role is of interest, please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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