Head of Regulatory Affairs - Immunology/Oncology
Job#: 2035146
Job Description:
Head of Regulatory Affairs – Immunology/Oncology 2035146
Location: Greater Boston, MA (Hybrid)
Therapeutic Area: Immuno-Oncology/Autoimmune
Job Overview: This role is for a knowledgeable and experienced Regulatory Affairs professional to lead the development of comprehensive regulatory strategies to support clinical stage activities, responsible for developing efficient strategies and coordinating medical activities for clinical development programs in cancer immunotherapy and autoimmune diseases.
Primary Job Responsibilities:
- Designs and implements regulatory strategies for clinical trial applications
- Oversees regulatory filings and serves as corporate liaison with regulatory agencies
- Provides regulatory guidance for project teams, department compliance, and to assure compliance
Primary Job Requirements:
- BS required, PhD (preferred) in biomedical sciences or related fields with 10 years of experience in biopharmaceutical industry and 7 years in regulatory strategy
- Expertise in regulatory submissions (IND and BLA), writing scientific and technical documents, non-clinical and clinical development, and regulatory guidelines of multiple agencies including international
- Demonstrated track record of regulatory meetings, submissions, and approvals
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