Regulatory Affairs Specialist
6 hours ago
We are looking for a Regulatory Affairs Specialist - CMC to join our team at RBW Consulting. The ideal candidate will have over 10 years of experience in CMC technical roles, with a focus on lifecycle management of small molecule products.
The successful candidate will manage CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and product quality reviews. This role requires effective stakeholder management, project management within a CMC context, and knowledge of IND/NDA and IMPD/MAA formats.
- Responsibilities:
- Manage CMC regulatory activities for clinical programs
- Author documents for INDs and IMPDs, respond to Health Authorities, and prepare QP release documents
- Collaborate with external CMOs and manage post-submission activities
- Requirements:
- Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products
- Pre- and post-approval CMC regulatory activities experience
- Effective stakeholder management, project management within a CMC context
- Knowledge of IND/NDA and IMPD/MAA formats, understanding of drug substance and product CMC
- Organized, independent, and able to manage multiple activities
- Degree in Pharmacy or a relevant science/technical subject, proficient in English, French is an advantage
We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off. The estimated salary for this role is $140,000 - $200,000 per year.
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