Regulatory CMC Associate at Hanover

Qualifications
- At least 3 years in regulatory project management preferred, and/or experience in drug/biopharmaceuticals.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
- Knowledge of the drug development process desirable.
- Ability to critically evaluate data from a broad range of scientific disciplines.
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent preferred.

Job responsibilities
- Provide and/or implement global CMC regulatory strategy for products.
- Lead or contribute to global CMC submission activities for assigned products, while applying the global strategy into submissions.
- Make quality regulatory decisions, balancing risks and benefits.
- Identify required CMC documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Contribute to cross-functional CMC Health Authority Response Teams for assigned products and prepare CMC responses, as appropriate.
- Assume specialized assignments as assigned.


Country: USA, State: New Jersey, City: Hanover, Company: Green Key Resources LLC.