Global CMC Regulatory Affairs Lead
2 weeks ago
We are seeking a skilled Regulatory Affairs professional to lead our global CMC regulatory strategy and ensure compliance with external requirements and internal quality procedures.
- Develop 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.
- Build strong relationships with internal and external partners, including regulatory authorities, to drive regulatory success.
The ideal candidate will have a degree in Natural Sciences, 6 years of pharmaceutical experience, and a minimum of 3 years of pharmaceutical regulatory experience. They will also have at least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations.
Benefits:
- Competitive salary
- Inclusive environment
- Career progression opportunities
- Work-life balance initiatives
About Us:
We are a global healthcare company dedicated to building a truly diverse, inclusive and authentic workplace. We believe in the importance of sustainability and corporate social responsibility, and we work to advance responsible and sustainable operations.
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