Regulatory Affairs Manager CMC Position
hace 4 días
Company Overview
Mabxience is a leading biopharmaceutical company dedicated to developing innovative medicines for the global market. Our team of experts is committed to delivering high-quality products that meet the highest regulatory standards.
Job Summary
We are seeking an experienced Regulatory Affairs Manager CMC to join our team in this critical role. The successful candidate will be responsible for ensuring compliance with all applicable national and international regulations, as well as providing regulatory relevant technical assistance to development teams.
About the Role
The Regulatory Affairs Manager CMC will support and promote all regulatory CMC tasks throughout the product lifecycle, under the supervision of a senior Regulatory Affairs department member and in collaboration with internal and external stakeholders. Key responsibilities include:
- Preparation and review of regulatory submissions such as INDs, CTAs, IMPDs, NDAs, BLAs, MAAs, and post-approval variations, annual reports, renewals, and responses to health authority questions (deficiency letters).
- Writing of regulatory CMC sections (e.g., Module 2 and Module 3) from product development and quality source documents, including compilation of regulatory submission packages in close collaboration with relevant stakeholders and applicable internal procedures.
- Ensuring that regulatory submission packages are scientifically adequate and include an appropriate level of detail, while ensuring compliance with all applicable national and international regulations.
- Regulatory evaluation of CMC change controls and maintaining product compliance throughout the product lifecycle.
- Supporting the execution of regional regulatory strategies, in line with business objectives and in cooperation with regional partner companies and internal/external stakeholders.
Requirements
To be successful in this role, you will need:
- A degree in Life/Health Sciences (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent. Advanced degree in Science preferred.
- Minimum 5 years of experience in Regulatory Affairs, preferably in the pharmaceutical industry.
- Proven track record of successfully managing regulatory submissions and ensuring compliance with national and international regulations.
- Excellent communication and project management skills, with ability to work collaboratively in a fast-paced environment.
What We Offer
Mabxience offers a competitive salary range of $120,000 - $150,000 per year, depending on experience, as well as a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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