Réglementaire Clinique — Expert Dossiers & Autorisations

AMARIS GROUP SA; France; Hybride; EUR 48 000 - 64 000; Plein temps

Avantages offerts par ce poste

Gym access

Lunch vouchers

Free Spanish classes

Remote policy: 2 days per week

Résumé du poste

AMARIS GROUP SA, a leading global technology consulting firm, is seeking a Regulatory Affairs professional in France to manage regulatory and legal aspects for studies and products. You will draft and submit documents to authorities, ensure compliance, and act as the main contact for regulators.

The role calls for a Master’s degree in Life Sciences or Pharmacy, with experience in regulatory affairs across pharma or regulated sectors. Remote work policy allows 2 days per week.

Qualifications

• Master’s degree in Life Sciences, Regulatory Affairs or Pharmacy.
• Experience in Regulatory Affairs within pharma, medical devices, cosmetics or regulated industry is a plus.
• Good understanding of regulatory requirements and submission processes.

Responsabilités

• Manage regulatory and legal aspects related to studies and products.
• Draft, prepare and submit regulatory documents and dossiers to authorities.
• Ensure review and validation of regulatory documentation per applicable requirements.
• Act as main point of contact for regulatory authorities and manage ongoing interactions.
• Prepare documentation to obtain, renew or update authorizations and certificates.
• Ensure products are manufactured and distributed in compliance with regulations.
• Monitor regulatory renewals and updates throughout the product lifecycle.

Connaissances

Regulatory Affairs

Life Sciences

Project management

Communication skills

Stakeholder management

Formation

Master’s degree in Life Sciences or Pharmacy

Description du poste

AMARIS GROUP SA, a leading global technology consulting firm, is seeking a Regulatory Affairs professional in France to manage regulatory and legal aspects for studies and products. You will draft and submit documents to authorities, ensure compliance, and act as the main contact for regulators.

The role calls for a Master’s degree in Life Sciences or Pharmacy, with experience in regulatory affairs across pharma or regulated sectors. Remote work policy allows 2 days per week.