Regulatory Affairs Project Manager (h/f) - (Womens' health)

Location: 

Chatillon, FR, 92320

Description Overview

As a major player in consumer health and cosmetics, Perrigo is an American pharmaceutical company committed to supporting the health and well-being of consumers through a unique portfolio of market-leading brands such as EllaOne® or Norlevo® (Women’s Health), Compeed® or Mederma® (Skincare), XLS Medical® (Weight Management) or also in many other categories (cough, cold, allergies, natural health…).

 

We are dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.

 

We are looking for a Regulatory Affairs Project Manager (h/f) to join our team in Chatillon. 

Scope of the Role

 

 

  • Maintains the quality system in relation to the scope of activities (creation/update if applicable of procedures, instructions, forms)
  • Participates in qualifications and documentary audits concerning the scope of activities Training of the personnel concerned on the scope of activities
  • Manages pre- and post-approval activities (variation, renewals, PSUR) to ensure the grant and maintenance of marketing authorization applications
  • Manages, reviews and organizes documents intended for submission to Health Authorities to ensure compliance with regulatory standards
  • Follows the registration procedures, coordinates the preparation of responses to questions from competent authorities
  • Represents Regulatory Affairs department during due diligence for MA  acquisition
  • Works as a central point of contact between the local distributors and internal departments for regulatory issues
  • Validates artworks and packaging materials in collaboration with the local RA office
  • Ensures Regulatory monitoring/watch in its territories
  • Participates in the review and preparation of Standard Operating Procedures (SOPs).
  • Ensure maintenance of the archives/trackers following SOPs & internal practices
  • Monitoring of promotional and information activities (corporate, national, international and congresses) managed by the Laboratory's head office in order to guarantee the regulatory compliance of activities. 
  • Organizes the validation of promotional and information documents (including website and social media) in accordance with the applicable regulations and guidelines and with the support of a local regulatory officer if necessary
  • Prepares and carries out the necessary administrative formalities with the competent authorities, if necessary, and with the support of a local regulatory officer if required
  • Transmits the necessary authorizations to the operations/communication department for production and dissemination of material
  • Assists the operations department in developing campaigns and promotional materials and validates training materials produced
  • Participates in the qualification (including audits) and review of contracts of regulatory consultants and distribution/promotion partners, ensuring compliance of compliance activities

Experience Required

  • Pharmacist/PhD
  • Additional training in health law and knowledge of the functioning of the pharmaceutical industry preferred
  • Very good experience in advertising control (ideally international) & its regulation
  • Strong experience & understanding in regulatory affairs (EU & WW) – Mostly independently running procedures: preparing files, answering RFI, managing timelines, demonstrating practical knowledge of all parts of the regulatory file
  • Independently develop strategies for moderate to significantly complex regulatory scenarios
  • Fluency in written and spoken English and French