Chargé(e) de Projet Réglementaire - all genders

卡湯晩; Neuilly-sur-Seine; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player in consumer healthcare is seeking a dedicated Regulatory Affairs professional to join their mission of simplifying self-care. This role involves engaging in supplier selection, implementing regulatory strategies, and coordinating supplier activities. The ideal candidate will have a strong background in Chemistry or Pharmacy, with a focus on Quality Assurance and regulatory compliance. Join a team committed to improving health outcomes and making a positive impact on society.

Qualifications

• 3+ years of experience in Regulatory Affairs within the pharmaceutical industry.
• Knowledge of CMC writing and operational Quality Assurance.

Responsabilités

• Participate in supplier selection and regulatory strategies.
• Coordinate supplier activities and assist in health authority inspections.

Connaissances

Regulatory Affairs

Quality Assurance

Organizational Skills

English Proficiency

Formation

Diploma in Chemistry or Pharmacy

Master's in Regulatory Affairs

Description du poste

Opella - Consumer Healthcare at Sanofi

Opella, the Consumer Healthcare business unit of Sanofi, is the third-largest global player in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We believe in the power of self-care to create a healthier society and planet. Our goal is to simplify self-care by being consumer-led and science-driven.

Our portfolio includes over 100 brands, with 15 high-growth challengers like Allegra, Dulcolax, and Buscopan, helping over half a billion consumers worldwide take charge of their health.

Our team of 11,000, along with 13 manufacturing sites and 4 innovation centers, brings this mission to life. We are proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.

Join Our Mission: Health. In Your Hands.

Responsibilities

1. Participate in supplier selection for pharmaceutical materials through documentation audits.
2. Implement and monitor regulatory strategies for supplier qualification and registration.
3. Coordinate routine supplier activities within the team.
4. Develop strategies for maintaining backup suppliers.
5. Contribute to writing and updating procedures.
6. Assist in health authority inspections.

Main Activities

Engage actively in project meetings, change committees, assess changes, review project documentation, update regulatory files, monitor submissions, and respond to authority inquiries.

Profile

• Diploma in Chemistry or Pharmacy, or at least 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Master's in Regulatory Affairs preferred.
• Experience in CMC writing (Module 3).
• Knowledge of operational Quality Assurance (supplier audits, complaints, deviations, CAPAs, change management).
• Proficiency in professional English (written and spoken).
• Organizational skills, rigor, and proactive approach.