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

Hiring By - Biostaffic

 BioPharma

France

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
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

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Perrigo Company Plc
Perrigo Company Plc

Current Openings: 0

Perrigo Company plc, is a global consumer self-care company. Our vision is: To make lives better by bringing "Quality, Affordable Self-Care Products" that consumers trust everywhere they are sold. Founded in 1887 as a packager of home remedies, Perrigo has transformed to a self-company which enables the empowered consumer to treat conditions that can be self-managed. Perrigo is the world's largest manufacturer of over-the-counter ("OTC") self-care products and supplier of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets.
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