Michael Page

Regulatory Affairs Senior Manager

Location
England, London / England, Essex / Hertfordshire, England
Salary
Negotiable
Posted
29 Jul 2021
Closes
26 Aug 2021
Ref
JN -072021-2951820
Contact
Chloe Baverstock
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
  • Exciting opportunity to join a well known and growing Pharmaceutical business. Primarily responsible for regulatory strategies during development, approval and post approval phases of submissions to EU Competent Authorities.

Client Details

I have partnered with a well known and growing Top Pharmaceutical business.

Description

Regulatory Affairs Senior Manager.

  • Primarily responsible for regulatory strategies during development, approval and post approval phases of submissions to EU Competent Authorities.
  • To obtain registrations for Specialty Respiratory products in Europe and to ensure that the registrations for existing marketed products are maintained.
  • To support cross-functional pre-MAA and post-MAA developments of Respiratory products.
  • Ensure that regulatory obligations for marketing authorisations are met and provide a point of contact for EMA or national competent authorities.
  • Ensure visibility of status and key issues for all developments within the team's remit from the point at which products are approved for development until launch and subsequently in lifecycle management.
  • Collaborate with internal/external cross-functional teams, providing European regulatory advice to the cross-functional project teams, Management, medical affairs and commercial on appropriate strategies for internal developments as well as in-licensing opportunities.
  • Proactively identify regulatory risks and ensure that remedial action is in place to address any perceived gaps in supporting data requirements. Escalate issues via the cross-functional team structure to R&D/Clinical/Commercial etc management to resolve complex issues.
  • Participate in the development of RA strategies for product submissions.

Profile

Regulatory Affairs Senior Manager

- Must have experience working with EU Regulations.

- Must have pre approval experience.

- Strong Scientific background with at least a BSc in a Life Science discipline.

- Experience in managing both new submissions and maintenance work.

Job Offer

Competitive Basic Salary + Brilliant Benefits

Similar jobs

Similar jobs