Regulatory Responsible

il y a 2 semaines

NeuillysurSeine, Île-de-France Opella Temps plein

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 into 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 are our 100+ loved brands, our 11,000-strong global team, 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 at

About the job

As Regulatory Responsible, you will lead CMC (Chemistry, Manufacturing, and Control) activities within the regulatory team, reporting directly to the Team Leader. Your role is critical to ensuring supply continuity by maintaining Marketing Authorizations for our drug products and driving regulatory strategies for rapid implementation when needed. You will be the CMC expert for all projects linked to your portfolio and a key contributor to business and innovation.

Main responsibilities

  • Manage CMC documentation: Write, update, and review regulatory CMC dossiers for submission; coordinate internal and external CMC writing; optimize dossier content for future changes; prepare responses to Health Authority queries.

  • Support Marketing Authorizations worldwide: Handle territory extensions, renewals, site registrations, and transfers by preparing CMC documents and collecting GMP-related documentation.

  • Change Control: Assess regulatory impact of product lifecycle changes; define regulatory strategies; track submissions and approvals of variations globally.

  • Ensure Regulatory Compliance: Align CMC dossiers with manufacturing and control procedures; evaluate compliance against current regulations; define corrective actions for gaps.

  • Act as the regulatory interface with Global and Affiliate Regulatory Affairs for EM CHC.

  • Support business units in managing new opportunities and product launches.

About you

Experience:

  • Hands-on experience in CMC writing and/or Regulatory Affairs.

  • Background in pharmaceutical industry within GMP environments (Quality Assurance, Development, Production, or Quality Control).

Skills:

  • Strong written and verbal communication skills; ability to collaborate across functions.

  • Excellent organizational skills with attention to detail and ability to manage multiple priorities.

  • Knowledge of global drug regulations (EU, FDA, ICH, China).

  • Familiarity with Veeva Vault RIM and Veeva Vault Quality is a plus.

Education:

  • Scientific degree in Pharmacy; Ph.D. in Pharmaceutical Sciences preferred.

  • Chemical or Biochemical Engineering background is an advantage.

Languages:

  • Proficient in English (written and spoken); additional languages are a plus.

Why us?

At Opella, you will enjoy challenging, purposeful work and the opportunity 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 thrive every day.

We Are Challengers.

  • 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 drive sustainable impact and results with integrity.
  • Radically Simple: We make things simple for us and for consumers, as it should be.

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

#LI-HYBRID

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