Associate Director, Regulatory Affairs, CMC
This role is considered Hybrid.
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Responsibilities :
The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs.
The Associate Director is a key member of multidisciplinary teams responsible for preparation of high-quality regulatory submissions focusing on chemistry, manufacturing, and controls (CMC) for lifecycle management and global expansions of the commercial programs.
This position reports to the Senior Director of Regulatory Affairs CMC, or equivalent.
Summary of Key Responsibilities :
Assists in the development and execution of a robust global regulatory CMC strategy using balanced, risk-based approaches for the commercial programs.
The role directly collaborates with cross-functional CMC and Global Regulatory Teams to achieve strategic company objectives.
- Leads and manages the preparation of high-quality CMC regulatory submissions.
- Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments.
- Actively participates in the development of regulatory CMC infrastructure and capability building.
Requirements :
- BS in science related field required, advanced degree (eg MS, PhD) preferred.
- Minimum 6-8 years of experience in the pharmaceutical / biotechnology / life science industry, including at least 4 years of regulatory affairs CMC experience, including direct experience in developing and executing global regulatory strategy.
- Sound understanding of chemistry and biology. Experience in oligonucleotides is a plus.
- Experience in managing complex submissions and CMC changes (eg process, facility, formulation) in a global setting.
- Knowledge and understanding of US, EU, Canada, and ICH guidelines. Understanding of international CMC requirements is a plus.
- Proven ability to develop creative regulatory solutions for expedited programs, rare diseases, and / or platform technology.
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts and internal or external partners.
- Excellent verbal and written communication skills.
- Demonstrated strong organizational skills including ability to derive and execute complex project plans.
- Highly computer literate (eg, Word, Excel, PowerPoint).
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