Senior Director, Regulatory Affairs, Oncology
Our client is a biopharmaceutical company focused on rare diseases. They have asked us to assist them in their search for a Senior Director, Regulatory Affairs, Oncology
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Develops global strategies and provides high level strategic and operational regulatory direction and mentorship on clinical development programs in oncology.
- Works closely with stakeholders in all functions.
- Provides regulatory project management with a focus on R&D for late stage global regulatory filings.
- Establishes and maintains real-time filing timelines.
- Tracks deliverables for components or modules of major submissions from filing through registration.
- Contributes to critical Filing team and sub-team meetings.
- Assists in the management and follow-through on project deliverables and outstanding action items between Nonclinical, CMC, Clinical and Regulatory sub-teams.
- Organizes the updating of project dashboards, status updates, and reports for sharing progress and risks with Filing team, sub-teams, and senior management team.
- Schedules and coordinates reviews and roundtables, as needed, per the regional filing timelines.
- Contributes to planning and support for cross-functional workshops focused on execution of submission strategy.
- Contributes to the development of best practices and standardized process for filing of regulatory submissions.
- Serves as co-leader for relevant BLA sub-teams with functional expert.
- Contributes to internal regulatory policies and procedures to achieve best practices and work processes by writing SOPs.
- Stays abreast of newly issued regulatory laws, guidance and technical publications.
- Supports regulatory activities for the oncology portfolio.
- Master’s degree within Life Science required.
- Must have a minimum of 10 years of experience in a Regulatory Affairs position of increasing responsibility with a pharmaceutical/biotechnology company developing biologics, small molecules, or synthetic peptides.
- Requires experience working as a Regulatory Affairs project lead of BLA and/or NDA filings.
- Experience working with a drug device combination product highly preferred.
- Must have a solid understanding of clinical development and how to present clinical data to FDA.
- Requires experience with labeling development and in close collaboration with marketing and market access departments.
- Must have extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labeling, interactions with Health Authorities, and experience in developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market.
- The demonstrated an ability to collaborate effectively with multiple functions, including Research, Development, Clinical, Commercial, and Quality is required.
- Requires the ability to travel up to 30-40 days per year, both domestically and internationally.
If interested, please email your resume as a Word attachment to us. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.