Global Regulatory CMC Lead

Opella•Morristown, NJ

1d•$127,000 - $170,500•Hybrid

About The Position

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.

Requirements

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).
Fluency in oral and written English

Nice To Haves

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.
Experience with GenAI tools in the CMC regulatory environment is a plus
Further languages are a plus

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