Associate Director, Global Regulatory Affairs CMC
I am currently working with a leading pharmaceutical in the Greater Boston area looking to add an Associate Director of Regulatory Affairs, CMC to the team. This role will play a key role in leadership within the company's CMC space at the global level. You will specifically perform strategic guidance for the Plasma Derived Therapies business unit and assist the company in development and life cycle management of their impressive pipeline.
Responsibilities:
- Contribute to the growth of multiple CMC regulatory strategies and registrations across the US, as well as in emerging global markets
- Providing guidance for life cycle management and regulatory strategies to support your specific business unit
- Provide knowledge regarding up to date CMC changes and regulations, as well as act as a representative for the CMC regulatory environment as it pertains
- Offering regulatory knowledge to stakeholders, as well as assessing regulatory and compliance risk
- Creating CMC documents including CTA's, NDS, and other filings
- Strong leadership skills, providing the ability to lead and mentor others as well as offer impressive knowledge on global drug discovery
- Offer knowledge of CMC regulations in international markets
- Strong communication, interpersonal, and leadership skills
Other Requirements
- Minimum of 4-7 years in biologics specifically
- Minimum of 4-7 years of CMC experience within regulatory affairs
- Experience in plasma derived therapies is a preference
- Experience within the global market of regulatory affairs