
CMC Regulatory Compliance Manager
7 days ago
The Role & What You Will Be Doing:
In this pivotal role, you will be responsible for ensuring global regulatory compliance by aligning with external requirements and internal quality procedures.
- You will demonstrate regulatory expertise, sharp decision-making, and collaboration to develop and execute regulatory strategies, manage submissions, and review policies.
- Create and execute robust regulatory strategies to mitigate risks and address technical and scientific challenges.
- Prepare and deliver high-quality CMC submissions to global regulatory agencies, managing timelines and ensuring alignment with regulatory commitments.
About Your Skills & Experience:
- A degree in Natural Sciences is required, along with 6 years of pharmaceutical experience, including relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years of pharmaceutical regulatory experience.
- At least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations.
- A solid understanding of cGMPs, development, and commercial activities is essential to assess the technical and regulatory merits of CMC data.
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