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Regulatory Chemistry Lead
2 semanas atrás
Overview:
We are seeking an experienced Regulatory Chemistry Lead to join our team in developing and executing regional CMC strategies for new marketing applications, Scientific Advice, and post-approval changes.
About the Role:
As a Regulatory Chemistry Lead, you will work closely with Global CMC RA Product Leads to ensure right-first-time submissions, high approval rates, on-target launches, and successful implementation to maintain patient supplies throughout the product lifecycle.
You will be responsible for ensuring that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial, and operational strategies. You will also support Organon Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions as a CMC content subject matter expert.
Key Responsibilities:
- Develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice, and post-approval changes.
- Collaborate with Global CMC RA Product Leads to ensure right-first-time submissions, high approval rates, on-target launches, and successful implementation to maintain patient supplies.
- Ensure alignment of regional CMC regulatory strategy with global regulatory strategy, Franchise portfolio, commercial, and operational strategies.
- Serve as Regulatory CMC SME in regional post-approval requirements, ensuring awareness of regional regulatory policy trends and maintaining/updating the regulatory intelligence repository for regional markets.
- Communicate proactively with Global CMC Product Leads on regional registration requirements, new legislation, and guidance, and provide timely updates of the CMC change management systems to support right-first-time submissions.
Requirements:
- Bachelor's or Master's Degree in chemistry, pharmacy, biology, or a related science.
- At least 4 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
- Experience in Regulatory Affairs for regional markets, with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing, and/or quality assurance.
- Effective problem-solving skills, understanding of regulatory strategies, excellent interpersonal skills, detail-oriented, and able to prioritize multiple tasks.
- Proven ability to communicate effectively in both written and verbal formats.
- Fluency in 1-2 languages spoken in the region of responsibility, in addition to English.
- Able to influence and work both independently and collaboratively in a team structure.