Senior Regulatory Affairs Manager

Job description

Your mission

Pierre Fabre USA is seeking a Regulatory Affairs Manager to join our team. This role will oversee regulatory compliance for the US affiliate and play a vital part in ensuring our products meet all local regulatory requirements.

The ideal candidate will manage all regulatory activities primarily for Cosmetics, with minor additional responsibilities for OTC drugs and Dietary Supplements marketed in the US, ensuring strict adherence to applicable legislation. This individual will act as the primary liaison with regulatory agencies, such as the FDA and FTC, while fostering effective communication and coordination with Corporate Regulatory Affairs, local marketing, and compliance teams.

Responsibilities:

Product Registration & Notification

·  Submits all registration, notification and product listing files for local or corporate Pierre Fabre products (OTC drugs, Cosmetics, Dietary supplements) to the appropriate local Authorities in accordance with the US legislation in force.
·  Ensures maintenance of marketing authorisations/notifications (e.g. renewals, variations, payment of fees as relevant, …) under OTC drugs and MoCRA regulations.
·  Ensure maintenance of Establishments under OTC drugs and MoCRA, as well as labeller code for PF USA.
·  Where applicable, creates and maintains regulatory files, documents, and data in the corporate databases RegulatoryOne and Amelis+.
·  Validates the acceptability of the ingredients in the formula, along with any mandatory regulatory mentions/warnings under the FDA or state regulations such as Prop65 or Toxic-Frere Kids Programs.
·  For local OTC drug or cosmetic products, assists in any regulatory activity during the development phase with the Contract Development and Manufacturing Organization (CDMO).
·  For all products developed and manufactured locally, prepares product Master Files in close collaboration with Corporate Regulatory Affairs.
·  For all future corporate products to be marketed in the US, evaluates the regulatory compliance and performs the necessary registration steps in a timely manner to allow easy importation from France.
·  Twice a year, coordinates the Brand advice meetings with Corporate Regulatory Affairs and local marketing teams. Performs regulatory evaluation and coordinates the necessary listing or notifications to be performed for the launch.
·  Informs immediately Corporate Regulatory Affairs about any question on a Pierre Fabre product raised by a local Authority. After prior validation by Corporate Regulatory Affairs, submits responses to request(s) for information from local Authorities.
·  Organises and prepares, in close contact with Corporate Regulatory Affairs, all necessary meetings with local authorities to solve any regulatory issue or to facilitate future local submissions.
·  Supports the Medical Information department in case of any technical questions from a health care professional/consumer association/organisation aiming on a product, as appropriate.
·  Maintains an up-to-date list of National Drug Codes and Cosmetic Product Listings with any relevant information such as approval date, first marketing date, marketing cessation, withdrawal of marketing authorisation, any reassessment of benefit/risk ratio imposed by Competent authorities.
·  For OTC products, performs all necessary periodic reporting such as Cares Act Amount reporting.
·  For all products, performs all necessary state reporting such as Fragrance allergen reporting in California.
·  Performs the product listing on external platforms such as WERCSmart and keeps them up to date.
·  Organizes the archiving and traceability of local files and documents.
·  Upon demand, sends periodic activity reports to Corporate Regulatory Affairs.
·  Assists in any regulatory activity needed to ensure customs clearance, distribution, and commercialisation according to local legislation.

Regulatory Material Review

·  Reviews and validates packaging information in accordance with the US legislation in force. Provides recommendation for improving regulatory compliance.
·  Reviews and validates local promotional materials in accordance with the US legislation in force.
·  Periodically checks US brand websites for compliance.

Regulatory watch and intelligence

·  Keeps up to date with the evolving local legislation for all types of products (OTC drugs, Cosmetics and Dietary supplements), and other regulatory status.
·  performs the survey / intelligence for all potential authorities (FDA, FTC, State regulations, etc).
·  performs the impact analysis on the local portfolio (for local and corporate products)
·  reports to the Corporate Regulatory Affairs through the appropriate tool (RainBow, for example)
·  Makes recommendations on US product launch strategy, as applicable.
·  Is a member of local industry associations such as Personal Care Products Council. Participates as needed to task forces and committees within the associations. Attends meetings and conferences as appropriate. Reports on these meetings, such as anticipated regulatory landscape evolution, FDA or FTC priorities, legal/lawsuit trends, etc.
·  Upon Corporate Regulatory Affairs request, participates in any internal meetings aiming at sharing regulatory evolutions and their impacts within the Pierre Fabre Group.
·  Works with the external consultant to maintain, renew and update our state licenses as necessary.
·  Acts as the Designated Representative for Pierre Fabre USA or its backup for state licenses.
·  Performs any mandatory state reporting associated with these licences, including periodic PF USA site audits.

Collaboration with other departments

·  Trains local marketing employees on the current regulations around promotional claims. Reviews promotional material and provides advice, alternative wording for desired claims.
·  Trains every new employee on quality and vigilance requirements and ensures all PF USA employees receive a yearly continuous training on these topics.
·  Collaborates with the Legal & Compliance department on any internal discussions, negotiations or litigious topic.
·  Coordinates import of new products with the Logistics team to ensure products can be legally sold in interstate commerce upon arriving in the US.
·  Collaborates with the CDMO team for local product development, clinical testing and desired claims.
·  Contributes to the routine activities of its Quality, Regulatory, Vigilance and Medical Information (QRVI) Department, including standard operating procedures, deviations, change controls, inspections, audits, etc.
·  Other duties as described by the business.

Required Education and Experience :

·  Scientific or medical degree (e.g., Pharmacist, Microbiologist, or Bachelor/Master’s degree in a relevant field.)
·  At least 3 years of experience within the pharmaceutical industry, specifically in regulatory affairs, with experience handling cosmetic and OTC products.
·  Excellent understanding of regulations in the cosmetic field.
·  Ability to interpret clinical study results and toxicological assessments in regulatory files and translate them into permitted claims.
·  Basic knowledge of OTC quality standards and requirements

Competencies: Analytical and Detail-Oriented : Demonstrates rigor, attention to detail, and strong analytical and synthesis capabilities. Adaptability and Proactivity : Shows flexibility and the ability to anticipate needs in a dynamic environment. Takes initiative and adapts to shifting priorities and projects. Personal Assertion and Open-Mindedness : Exhibits confidence and assertiveness while maintaining an open-minded approach to collaboration and problem-solving. Team-Oriented : Values team spirit and works effectively in collaborative environments. Project Management and Timeliness : Skilled at managing multiple ongoing projects while meeting strict timelines.

Work Environment / physical demands / position type and expected hours of work:

·  This job operates in a clerical, office setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. 
·  This is a largely sedentary role; however, some filing is required, which would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. 
·  The normal working hours of the office are from 8:30 a.m. – 5:00 p.m. Monday through Friday.
·  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel (Not relevant)

Pierre Fabre has been recognized by Forbes as one of the " World's Best Employers " for the 3rd year running. 

True to My Nature

https://www.pierre-fabre.us/

Who you are ?

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.