Manager to Sr. Manager, Regulatory CMC

Job Description

• Provide leadership and knowledge-based support for biologics and small molecules CMC activities • Manage clients and stakeholders • Work with the Director CMC US to support business development • Provide critical technical review of documentation • Support client’s regulatory agency meetings

Qualifications

• Bachelor’s degree in chemistry • 10+ years of experience in CMC pharmaceutical development or regulatory experience • Established experience in regulatory affairs activities • Strong written, verbal, and presentation communication skills • Ability to adapt under changing conditions

Benefits

• Up to 20% travel expectations • Remote position