Associate Director Regulatory Affairs
Company Summary:
My client, a global, leading chemical manufacturer focusing on providing innovative therapies for many therapeutic areas including oncology, immunology, and metabolic diseases is looking to add an Associate Director of Regulatory Affairs to the team! They have been industry leaders in innovation for over four decades and are known for their work-life balance and company culture! This role will be hybrid based in Cambridge, MA.
The Associate Director will be responsible for:
- Timely and accurate submission of IND, NDA, or BLA
- Reviewing archived regulatory applications and assessment of any clinical hold issues
- Experience meeting with the FDA and other health authorities
- Experience in oncology is preferred
The Associate Director should have the following qualifications:
- 5+ years of pharmaceutical industry experience
- Advanced degree in life sciences
- Experience in submission of regulatory applications and meeting requests
- Strong communication skills
