About the RoleThe Director / Senior Director of Regulatory Affairs serves as a strategic leader responsible for developing and executing regulatory strategies to support product development and commercialization. This senior position oversees all regulatory activities and is responsible for ensuring compliance with global standards and timely product approvals. This position will work closely with outside regulatory subject matter experts, senior leadership, clinical development, manufacturing, and other internal/external stakeholders to maintain a strong regulatory culture within the organization.
Employment Type Full-time
Reports To SVP, Clinical and Medical Affairs
Key Responsibilities- Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions
- Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries
- Oversee preparation and submission of regulatory documents
- Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals
- Provide strategic input to leadership on regulatory risk and risk mitigations
- Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders
- Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness
- Represent regulatory interests in product development governance committees and decision-making processes
Required Qualifications- Advanced degree in life sciences, pharmacy, or related field preferred
- 10+ years of progressive experience in regulatory affairs within the biotechnology/pharmaceutical industry
- Minimum of 5 years experience in the hematology/oncology field
- Demonstrated track record of successful regulatory submissions and agency interactions
- Comprehensive understanding of FDA, EMA, and other major health authority regulations
- Experience with successful product approvals
- Strong leadership abilities with 3+ years managing regulatory teams
- Excellent communication and interpersonal skills for effective cross-functional collaboration
- Strategic thinking with ability to translate complex regulatory frameworks into practical guidance
- Demonstrated ability to work collaboratively with internal and external stakeholders to achieve consensus in complex and ambiguous situations
- Deep knowledge of GxP requirements and their implementation
- Ability to operate in a fast-paced environment
Salary- $212,000 - $290,000 (depending on experience and job level)
