Regulatory Affairs Lead, Chemistry Manufacturing Specialist
1 week ago
We are seeking a highly skilled Regulatory Affairs Lead, Chemistry Manufacturing Specialist to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies for assigned projects.
Key Responsibilities- Act as CMC regulatory lead or deputy for complex projects/products, requiring advice from the manager on complex issues.
- Manage technical documents for preparation, review, and submission to regulatory agencies. Prepares INDs/CTAs NDAs/MAAs, amendments supplements, as well as responses to questions from regulatory agencies.
- Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy.
- Ensures proper CMC Dossier Management, including document version control.
- Ensure compilation and transmittal of submissions are within defined schedules and meet Health Authority and Astellas established standards/SOPs.
- Proven expertise in an aspect of pharmaceutical drug development.
- Knowledge of Health Authority and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
- Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
What We Offer- A competitive salary range of £60,000 - £80,000 per year.
- The opportunity to work with a dynamic and growing company.
- A collaborative and supportive team environment.
To apply for this role, please use the link below: Apply on Lifelancer Platform
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Addlestone, Surrey, United Kingdom Lifelancer Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Lead, Chemistry, Manufacturing to join our team at Lifelancer.Job Description:The successful candidate will be responsible for developing regulatory CMC strategy for assigned projects. This includes identifying and collecting CMC data required for regulatory submission packages, planning and...
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