Regulatory Affairs Director, France

Job Description

General Summary:

As Regulatory Affairs Director and member of the Country Leadership Team, management of company Marketing Authorizations (MA) at the country level. As Responsible Person, contributes to the general management of Vertex Pharmaceuticals (France) as a Exploitant pharmaceutical establishment and responsible for all pharmaceutical operations (e.g. GMP, Public Health Code, supervision of promotional material).

Key Duties and Responsibilities:

• Member of the Vertex France Leadership Team advising on regulatory requirements for the Vertex marketed and pipeline portfolio.
• Act as the contact person for the health authorities and professional organizations.
• Implement regulatory/legal surveillance
• Ensure that each employee of Vertex Pharmaceuticals (France) SAS receives high-level initial and ongoing training in regulatory area (Exploitant / Charter on Information / GMP / GDP) enabling them to develop knowledge and skills that match their position, in conjunction with the Human Resources Director.
• Contributes to ensure the operational relationship with the MA holder (functional link with the International Quality Director of Vertex Pharmaceuticals Europe Ltd) and with any pharmaceutical supplier in order to guarantee regulatory compliance and the regular updating of quality specifications with suppliers.
• Implementation, monitoring and update of the processes for controlling advertising in accordance with the provisions of the Public Health Code and jurisprudence with a delegation from the medical department for the validation of scientific information.
• Management of technical product complaints
• Management of medical information
• Ensure compliance with all Vertex Pharmaceuticals (France) SAS and Vertex global SOPs, policies and quality system requirements
• Responsible for the monitoring of the batches, the processing of technical product complaints and the withdrawal and return of products if applicable.
• Ensures that quality audits of pharmaceutical suppliers are carried out at regular intervals
• Standard Responsible Person duties related to compliance to the activities of an Exploitant pharmaceutical laboratory, professional ethics and all other pharmaceutical operations.
• Responsible for the creation of the application for the opening of the Exploitant pharmaceutical establishment which is submitted to the ANSM in accordance with pharmaceutical regulations.
• Organizes and supervises the operations of manufacture, advertising, information, pharmacovigilance, batch monitoring and withdrawal, distribution, import and export of medicinal products, as well as the corresponding storage operations.

- ensure that the conditions of transport guarantee the proper conservation, integrity and safety of these medicinal products, products, objects or articles;

- signature for marketing authorization submitted by the company

- participates in research and study programs related to France;

- authority over delegated and assistant pharmacists

- implements all necessary means to ensure regulatory compliance

- general reporting to the ANSM in compliance with falsified medicines legislation

- responsible for deputy in case of absence

Knowledge and Skills:

• Good knowledge of French and European Legislation regarding the activities of an Exploitant pharmaceutical establishment.

Education and Experience:

• Pharmacist, qualified for a registration in section B. Training in Pharmacovigilance. Preferably with a PhD having a healthcare law degree.
• At least 10 years’ experience in an Exploitant pharmaceutical establishment as Responsible Pharmacist or Responsible Pharmacist Deputy.

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Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com