Senior Regulatory Affairs Associate, 12 mth FTC

Location: 

London, GB, SW11 7BW Ghent, BE, 9050

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.  Help us do it.


 

Description Overview

 

In this role, you will work on Regulatory Affairs projects and product changes as required to meet business needs.
You will also ensure compliance with the existing legislation and regulations for medicines.

Scope of the Role

 

1. Work as part of a multi-functional team by providing regulatory input to new product development and associated supporting documentation, complete due diligence on time for any assigned product dossiers.

 

2. As part of the team ensure product registrations are correct and compliant with the relevant legislation you will:

 

  • Establish, review, approve and update regulatory documentation
  • Prepare and publish packages and submit MAA’s and variations to meet the business needs via the electronic platforms
  • Maintain accurate and complete records by updating the relevant trackers, product folders and regulatory databases
  • Approve Artwork and Texts from a regulatory perspective
  • Participate in project meetings with both internal and external contacts
  • Communicate with local regulatory authorities regarding license applications and variations
  • Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes

 

3. Maintain oversight of the assigned projects, keep informed of any issues affecting product compliance or supply to market and take prompt action when urgent issues arise. Follow up closely with stakeholders to ensure resolution and timely closure of such issues

 

4. Support marketing and sales with claims creation and copy review, as per internal guidelines

 

5. Provide input for analysis of data and/or management review, if required

 

6. Carry out other related regulatory affairs duties as required

Experience Required

 

  • A scientific degree in a pharmaceutical, chemical or biological discipline.
  • 3 years Regulatory Affairs, ideally within UK or EU OTC including Post Marketing Licence Maintenance activities and submission of MAAs. 
  • Self-motivated, flexible and open to changing requirements 
  • Highly driven with enthusiasm to meet requirements and cope under demanding pressure
  • The ability to work autonomously and in a team
  • The ability to lead and support several concurrent projects/products
  • Excellent project management and administrative skills
  • Excellent communication in English
  • Excellent problem-solving skills
  • Being thorough, focused and detail oriented

 

We are an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.  Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV