Clinical Regulatory Affairs Specialist (Remote 2d/wk)

Amaris Consulting; Paris; Hybride; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Remote-friendly policy: 2 days remote

International community

Internal Academy with 250+ modules

ESG commitments

Résumé du poste

Amaris Consulting in Paris is seeking a Regulatory Affairs professional to support a leading client in managing regulatory activities for studies and products. You will handle compliance across submissions and maintain alignment with regulatory requirements.

Responsibilities include drafting and submitting dossiers, reviewing documents, and acting as the primary contact with authorities. A life sciences or pharmacy background and experience in regulated industries are required to excel in this

Qualifications

• Master’s degree or pharmacy-related education in Life Sciences, Regulatory Affairs or similar.
• Background in pharmaceutical studies or regulated industry is preferred.
• Experience in Regulatory Affairs within pharma/medical devices/cosmetics is advantageous.

Responsabilités

• Manage regulatory and legal aspects related to studies and products.
• Draft, prepare and submit regulatory documents and dossiers to authorities.
• Review and validate regulatory documentation per applicable requirements.
• Act as main contact for regulatory authorities and manage 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

Organizational skills

Stakeholder communication

Regulatory literacy

Formation

Master’s degree in Life Sciences, Regulatory Affairs or related field

Degree in Pharmacy

Description du poste

Amaris Consulting in Paris is seeking a Regulatory Affairs professional to support a leading client in managing regulatory activities for studies and products. You will handle compliance across submissions and maintain alignment with regulatory requirements.

Responsibilities include drafting and submitting dossiers, reviewing documents, and acting as the primary contact with authorities. A life sciences or pharmacy background and experience in regulated industries are required to excel in this