Regulatory Affairs Manager - High Wycombe, United Kingdom - Page Group

Page Group
Page Group
Verified Company
High Wycombe, United Kingdom

2 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description
Regulatory Affairs Manager where you will principle responsibilities will be within Consumer Health OTC medicines.

  • Assisting in regulatory support for other product types such as Cosmetics, Medical Devices and Food Supplements.

Client Details


Take the opportunity to become part of the success story behind one of the world's fastest growing consumer health care companies.

With a truly unrivalled brand portfolio with power brands across multiple categories. We have achieved consistent growth andour breakthrough plans make this a great place to further your career.


Description

  • Overall responsible for assigned portfolio of Consumer Health products and processes for UK, Ireland and/or Malta markets.
  • Maintaining and seeking new marketing authorisations through the National and European Procedures (Mutual Recognition and Decentralised Procedures).
  • Develop and support regulatory strategies (local and regional) in line with business plan.
  • Portfolio responsibility for full life cycle management including local responsibilities to define and implement submission strategy for existing marketing authorisations e.g., Safety changes (e.g. Company Core Data Sheets, PRAC, excipient updates etc ),Module 3 changes, Product Information updates (SmPC, PIL, Label), Reclassifications, Renewals etc.
  • Support the monitoring of local regulatory intelligence for the Consumer Health portfolio responsibilities.
  • Provide expert knowledge of the local regulatory authority (MHRA, HPRA etc.).
  • Strong collaboration with the local commercial teams, Northern Europe regulatory team and regional regulatory team to seek, shape and implement business plans and regulatory strategy.
  • Ensure efficient compliance to external, local, regional legislation and internal compliance obligations and requirements ensuring local and global databases are kept up to date.

Profile

  • Pharmaceutical or scientific university degree.
  • Works independently to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
  • Work with mínimal supervision to determine and develop approaches to solutions with technical guidance on the most complex problems.
  • Project management, understanding of regulatory environment, interaction with the Regulatory Authorities, commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.
  • Experience and knowledge of local UK, Irish and Maltese Regulatory Affairs requirements for pharmaceutical products.
  • Preference for OTC Regulatory Affairs experience and desirable to have a working knowledge of Cosmetic Regulatory Affairs.
  • Advanced Proficiency in English.

Job Offer

  • Competitive Salary
  • Allowances
  • Company Benefits
More jobs from Page Group
See all jobs of Page Group