Position Summary:
The Director, Regulatory Labeling will lead the development and management of clinical and commercial labeling for Olema’s products, reporting to the VP of Regulatory Affairs and Quality Assurance. This includes overseeing global regulatory labeling strategies, ensuring compliance, managing external vendors, and supporting major regulatory submissions.
Key Responsibilities:
- Oversee clinical and commercial labeling development across global markets.
- Collaborate cross-functionally with Clinical Supply, QA, CMC, and Regulatory teams.
- Develop SOPs, labeling processes, tracking tools, and dashboards.
- Manage labeling documents (e.g., USPI, SmPC, CCDS, SPL, CSI).
- Lead interactions with Health Authorities on labeling matters.
- Ensure timely artwork creation and approval for regulatory submissions.
- Represent Regulatory Labeling in cross-functional teams and executive meetings.
Requirements:
Knowledge & Experience:
- Bachelor’s (scientific field preferred); Master’s a plus.
- 10+ years in pharma/biotech; 8+ years in Regulatory Affairs.
- 3–5 years in a leadership role.
- Deep knowledge of FDA/EMA labeling requirements.
- Experience with NDA/BLA submissions and Oncology product labeling.
- Familiarity with GMP, ICH, and global labeling compliance.
Skills & Attributes:
- Strong project management and cross-functional leadership.
- High attention to detail, critical thinking, and communication skills.
- Able to work independently and manage multiple projects in a fast-paced environment.
Other Details:
- Location: Cambridge, MA or San Francisco, CA.
- Travel: Up to 10%.
- Compensation: $230,000–$245,000 base salary + equity, bonus, and benefits.
Job sourced from Olema Oncology.