Regulatory Affairs Specialist 169

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

Résumé du poste

An established industry player is on the lookout for a detail-oriented Regulatory Affairs Specialist to join their dynamic team in Courbevoie. This role is pivotal in ensuring compliance with regulatory standards for pharmaceutical products globally. You will prepare and submit essential regulatory documents, collaborate with cross-functional teams, and oversee clinical trial compliance. With a strong emphasis on communication and attention to detail, this position offers the chance to make a significant impact in a fast-paced environment. If you are passionate about regulatory affairs and eager to contribute to the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in regulatory affairs within the pharmaceutical industry.
• Strong knowledge of EU regulatory requirements for drug development and marketing.

Responsabilités

• Prepare and submit regulatory documents like INDs, NDAs, and BLAs.
• Collaborate with teams to ensure compliance from research to commercialization.

Connaissances

Regulatory Compliance

Communication Skills

Attention to Detail

Pharmacovigilance

Project Management

Formation

Bachelor’s degree in Pharmacy

Bachelor’s degree in Life Sciences

Description du poste

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Regulatory Affairs Specialist 169, Courbevoie

Client:

ProductLife Group

Location:

Courbevoie, France

Job Category:

Other

EU work permit required:

Yes

Job Reference:

8cd9f49f07c7

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:

• Prepare and submit regulatory documents (INDs, NDAs, BLAs, MAAs, etc.)
• Ensure compliance with laws, regulations, and guidelines established by regulatory agencies and national regulatory authorities
• Collaborate with cross-functional teams during product development to ensure regulatory compliance from the early stages of research and development through to commercialization
• Oversee the development of product labeling and packaging materials to ensure compliance with regulatory requirements
• Manage regulatory aspects of clinical trials, including obtaining regulatory approvals, ensuring compliance with Good Clinical Practice (GCP) guidelines
• Monitor and report adverse events and other safety issues associated with pharmaceutical products to regulatory authorities as required by pharmacovigilance regulations
• Work closely with quality assurance and quality control teams to ensure that pharmaceutical products are manufactured, tested, and distributed in compliance with current Good Manufacturing Practice (cGMP) regulations
• Prepare for and participate in regulatory inspections and audits conducted by health authorities

Experience:

• Bachelor’s degree in pharmacy, life sciences, or a related field
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry
• Strong knowledge of regulatory requirements for drug development, approval, and marketing in the EU, and other major markets
• Excellent written and verbal communication skills in French and English, with the ability to effectively communicate complex regulatory requirements to cross-functional teams
• Proven ability to work independently and collaboratively in a fast-paced environment, with a strong attention to detail and accuracy
• Experience with regulatory submissions and interactions with health authorities is preferred
• Familiarity with pharmacovigilance regulations and adverse event reporting is a plus