Chargé(e) de Projet Réglementaire

Opella; Neuilly-sur-Seine; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A global health and wellness company in Île-de-France is seeking a Regulatory Affairs professional with a diploma in Chemistry or Pharmacy and at least 3 years of experience in the pharmaceutical industry. This role involves supplier selection, regulatory strategy implementation, and routine supplier coordination to uphold quality standards. Strong English communication skills and CMC writing experience are essential. Join a passionate team dedicated to making self-care as simple as possible.

Qualifications

• Experience of at least 3 years in Regulatory Affairs in the pharmaceutical industry.
• Strong communication skills in English, both written and spoken.

Responsabilités

• Participate in the selection of suppliers of Materials for Pharmaceutical Use.
• Implement the regulatory strategy and monitor regulatory actions.
• Define the strategy for maintaining back-up suppliers.

Connaissances

Diploma in Chemistry or Pharmacy

Operational Quality Assurance knowledge

Professional English written and spoken

Organizational qualities

CMC writing experiences (Module 3)

Formation

Master of Regulatory Affairs

Description du poste

Opella is the self‑care challenger with the purest and third‑largest portfolio in the Over‑The‑Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission: to bring health in people’s hands by making self‑care as simple as it should be for over half a billion consumers worldwide.

At the core of this mission is our 100+ loved brands, our 11,000‑strong global team, our 13 best‑in‑class manufacturing sites and four specialized science and innovation development centers.

Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet.

Find out more about our mission to bring health in your hands at www.opella.com.

Missions

• Participate in the selection of suppliers of Materials for Pharmaceutical Use by carrying out the documentation audit
• Implement the regulatory strategy, coordinate, carry out and monitor the regulatory actions identified as part of the qualifications and registrations of suppliers
• Coordinate the routine implementation of suppliers within the team
• Define the strategy for maintaining “back‑up” suppliers
• Participate in the writing and maintenance of procedures
• Participate in health authority inspections

Main Activities

Active participation in project meetings, change committees, assessment of changes, assessment and review of project‑related documentation, update of regulatory files and monitoring of submissions, responses to questions from authorities

Profile

• Diploma in Chemistry or Pharmacy or experience of at least 3 years in Regulatory Affairs in the field of the pharmaceutical industry
• Master of Regulatory Affairs
• CMC writing experiences (Module 3)
• Operational Quality Assurance knowledge (supplier audits, complaints, deviations, CAPAs, change management)
• Professional English written and spoken
• Organizational qualities, rigor, strength of proposal

Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We Are Dedicated To Making Self‑care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things.

All In Together:

We keep each other honest and have each other's backs.

Courageous:

We break boundaries and take thoughtful risks with creativity.

Outcome‑Obsessed:

We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple:

We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers