Regulatory Affairs Specialist 192 193

TN France; Courbevoie; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

An established industry player is seeking a detail-oriented Regulatory Affairs Specialist to ensure compliance with global regulatory requirements in the pharmaceutical sector. This role involves preparing crucial documentation for product approvals and maintaining up-to-date knowledge of international guidelines. The ideal candidate will have extensive experience in Regulatory Affairs, particularly with European authorities, and possess strong organizational and communication skills. Join a dynamic team where your expertise will contribute to the successful development and marketing of innovative pharmaceutical products.

Qualifications

• 5-8 years of experience in Regulatory Affairs internationally.
• Strong knowledge of MLA, MAA, and CTD processes.
• Experience with European Regulatory Authorities.

Responsabilités

• Prepare and submit Manufacturing License Applications and Marketing Authorisation Applications.
• Ensure compliance with national and international regulatory guidelines.
• Act as a liaison between the company and regulatory agencies.

Connaissances

Regulatory Affairs

Compliance

Documentation Preparation

Communication Skills

Organizational Skills

Formation

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Outils

Microsoft Office Suite

Veeva Vault

Trackwise

PromoMat

LorenZ

Description du poste

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Regulatory Affairs Specialist 192 193, Courbevoie

Client:

ProductLife Group

Location:

Courbevoie, France

Job Category:

Other

EU work permit required:

Yes

Job Reference:

7eb2b80704ab

Job Views:

1

Posted:

29.04.2025

Expiry Date:

13.06.2025

Job Description:

We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally).

Responsibilities:

• Preparation and submission of Manufacturing License Application (MLA)
• Preparation and submission of Technical/Site Transfer Applications
• Preparation and submission of Marketing Authorisation Applications
• Preparation and submission of documentation for post-approval applications including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling
• Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation
• Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
• Ensuring compliance with the regulations of the assigned Countries within European and International Regions
• Act as a liaison between the pharmaceutical company and the regulatory agencies
• Support internal requests for information

Experience:

• 5-8 years of relevant experience in Regulatory Affairs internationally
• Lifecycle maintenance experience
• Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling Applications
• Experience working with European Regulatory Authorities
• Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
• Good organizational and communication skills
• Ability to prioritize and deliver high-quality work
• Experience in people management/coordination is a plus
• Experience in promotional/non-promotional activities is a plus