Regulatory Affairs CMC Responsible

Salary Range:

Ft11,680,000.00 - Ft15,573,333.33

All Compensation will be determined commensurate with demonstrated experience.

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You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self‑care works for millions of people and need experts ready to shape what’s next. As a Regulatory Affairs CMC Responsible, you’ll bring your expertise, curiosity and drive to make health simpler, smarter and more human. About the job The Regulatory Responsible – CMC plays a key role in leading Chemistry, Manufacturing and Control activities within the regulatory team. This position ensures supply continuity by maintaining Marketing Authorizations and driving effective regulatory strategies across the product lifecycle. Acting as the CMC expert for the assigned portfolio, you will contribute directly to business continuity, innovation, and global regulatory excellence. Main responsibilities Lead the preparation, review and optimization of CMC regulatory dossiers to support global submissions and lifecycle management Coordinate internal and external stakeholders involved in CMC documentation and ensure consistency and quality of submissions Define and drive regulatory strategies for product changes, ensuring timely approvals across multiple markets Assess regulatory impact of manufacturing or process changes and actively participate in change control activities Ensure alignment between CMC dossiers and manufacturing practices at CMOs, maintaining compliance with global regulations Support interactions with Health Authorities, including preparation of responses and regulatory documentation Act as a key regulatory interface across global and local teams, supporting product launches and business opportunities About you Proven experience in CMC writing and/or Regulatory Affairs within the pharmaceutical industry Experience in a GMP environment (Quality, Manufacturing, Development, or QC), with strong exposure to compliance topics Strong communication skills, with the ability to collaborate effectively across cross-functional teams Ability to manage multiple priorities and timelines in a fast-paced environment High level of organisation, attention to detail, and problem-solving mindset Self-motivated, proactive, and able to work independently Solid knowledge of global regulatory requirements (EU, FDA, ICH, China) Familiarity with Veeva Vault RIM and/or Veeva Vault Quality is a plus Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field PhD or advanced scientific education is a plus Fluency in English (written and spoken) Additional languages are considered an advantage. This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella. About Us 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 is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.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 4 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. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. #LI-HYBRID