Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Core
Lead global CMC regulatory strategies for hematology and oncology drug and biologic portfolios, guiding activities from development through approval and post-approval.
Role type
Associate Director, CMC Regulatory Affairs
Builds
Regulatory filings (INDs, BLAs, MAAs) and approval pathways for biological products
Domain
Pharmaceutical/Biotech, Hematology/Oncology, CMC Regulatory Affairs
Deliverable
client delivery
Required skills
CMC regulatory strategy, regulatory filing document review, interaction with global regulatory authorities, compliance assessment, SOP development, team mentorship
Preferred skills
Biological product development experience, device regulatory requirements, combination product development
Technologies
None stated
Responsibilities
Lead product development activities from a CMC regulatory standpoint; Represent CMC RA at program meetings and provide regulatory interpretation; Identify program issues and develop regulatory strategies to mitigate risks; Critically review and provide input on regulatory filing documents; Lead and facilitate interactions with global regulatory authorities; Perform final review and approval of compliance activities; Mentor colleagues in compliance assessments; Develop working instructions, SOPs, and templates; Identify gaps in processes and initiate operational changes; Manage and coach team members
Seniority
Senior, hands-on IC with mentorship responsibilities
