- Support Opella's mission to simplify healthcare by bringing OTC medicines and nutritional products to consumers worldwide
- Serve as a Global Regulatory CMC Lead within the Global Regulatory CMC Team
- Act as the subject matter expert on Chemistry, Manufacturing, and Controls (CMC) regulatory requirements
- Ensure OTC and nutritional products meet all regulatory and quality standards for market approval
- Help drive efficient and timely product development and market entry
- Collaborate with cross-functional teams to support regulatory strategy and execution
- Maintain compliance while enabling innovation and product availability at a global scale
Main Responsibilities:- Lead the global CMC regulatory strategy for innovation and lifecycle management projects
- Partner with cross-functional teams to accelerate product development timelines
- Manage regulatory submissions across major markets (FDA, EU, etc.)
- Provide expert guidance on CMC regulatory requirements, timelines and risk mitigation
- Represent Opella in regulatory authority meetings and scientific advice meetings
- Provide CMC regulatory contribution, review and expert recommendation to the CMC writer within Development and Manufacturing & Supply units.
- Lead CMC dossier development for clinical trials, product registrations and changes
- Manage regulatory databases for planning and tracking of regulatory submissions.
- Provide CMC claim recommendations to Brand Teams.
- Perform Due Diligence of regulatory CMC dossiers.
- Drive CMC regulatory intelligence to anticipate and adapt to changing global requirements
- Strategic and think-out-of-the-box mindset with strong business acumen
- Excellent communication skills for diverse stakeholder management
- Proven ability to work effectively in teams and matrix organizations
- Self-motivated with entrepreneurial spirit
- Excellent oral and written presentation skills
- Capability to mentor and train staff is a plus.
About You:- Bachelor's Degree plus Advanced degree (MS/PhD) in Pharmaceutics, Chemistry, or related scientific field
- 5+ years global regulatory CMC experience with proven FDA/EU approval track record
- Hands-on experience with OTC medicines and nutraceutical products for innovation and life-cycle management
- Proficiency in using Veeva RIM and other digital tools (eCTD viewer, MS Word, Excel, PowerPoint, Sharepoint).
- Experience with GenAI tools in the CMC regulatory environment is a plus
- Fluency in oral and written English
- Further languages are a plus
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.The salary range for this position is:
127,000.00 - 170,500.00 USD Annual
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs.
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