Senior Manager Regulatory Affairs

  • Job Reference: 620219768-2
  • Date Posted: 9 June 2022
  • Recruiter: SRG
  • Location: Maidenhead, Berkshire
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Temporary

Job Description

SRG are partnered with Abbvie, a Biopharmaceutical company who are searching for a Senior Manager Regulatory Affairs based in Maidenhead, England on an initial 6 month basis.

The Role:

Supports the implementation of registration strategy for assigned products in the Europe Region. Supports assigned product maintenance and lifecycle management submissions.
Supports clinical trials strategy as required.
Has some experience with regulatory procedures and contributes to the effective functioning of the Europe Region Regulatory Affairs team.
Contribute, as required, in the development of regional processes.
Develops and maintains knowledge of regulatory procedures and environment within the region.

Key Responsibilities:

Responsible for ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence.
Plans and implements regulatory activities in support of lifecycle management and maintenance in the region.
Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging.
Provides appropriate Europe Region regulatory input to project teams.
Ensures planned drug development activities comply with guidelines.
Makes recommendations to Global Regulatory and drug development teams.
Supports the drug development strategy.
Defines Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues.
Responsible for implementing and ensuring effective planning, tracking, archiving of activities.
Supports the communication of regulatory strategy in support of new product registration.
Follows core GRA policies and procedures.
Support implementation of new processes and input into changes in processes.
Provides forecasts and actuals and manage in line with regional requirements.
Follow all approved regional procedures and guidance.

Skills/Experience Required:

Education and Experience

Graduate in Life Sciences in a relevant area.
Some knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
Prior relevant experience in pharmaceutical industry or Regulatory Affairs

Essential Skills and Abilities

Ability to plan and organise workload including managing multiple projects. Ability to work effectively and collaboratively across the Allergan organisation.
Good interpersonal and negotiation skills. Good communication skills, both written and verbal (in English).
Willingness to travel as necessary.
Computer literate

If you are interested in this role or would like more to find of more about this role please contact me on (url removed) or on +(phone number removed)