ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS
We are seeking an exceptionally talented and motivated individual to join our team as Associate Director/Director, Regulatory Affairs. This position will be responsible for developing and executing innovative regulatory strategies in support of the nonclinical and clinical development for our early development pipeline products within the Regulatory Affairs department. In this lead, direct role, the successful candidate will provide dynamic leadership and direction to senior management and product development teams and will work in close partnership with the nonclinical and clinical leadership to achieve development milestones in an efficient and compliant manner. The role would require a strong scientific background with understanding and experience in GLP, GCP, and relevant regulatory guidelines to contribute to and shape the overall clinical development strategy.
The successful candidate will interface cross-functionally in a matrixed environment to integrate nonclinical and clinical plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
Key responsibilities:
- Manage all aspects of nonclinical and clinical regulatory strategy development for our products (early- to late-stage/registration/post-market).
- Lead teams in examining regulatory strategy options, provide relevant regulatory guidance.
- Identify and assess regulatory risks and critical-path activities associated with nonclinical and clinical development programs and work to identify regulatory strategies to mitigate risks.
- Monitor and analyze regulatory agency activities regarding nonclinical and clinical development and assess potential impact on our development programs and understand the regulatory landscape.
- Serve as Regulatory Lead on cross functional project teams to achieve project milestones/goals.
- Lead global regulatory submission development - Responsible for planning, coordinating, and developing high quality, compliant and timely regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).
- Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Qualifications:
- Master's degree in life sciences, or advanced degree preferred.
- Prior experience with cell or gene therapies
- Prior experience in oncology drug development
- 10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
- Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
- Ability to lead matrixed teams, drive and influence effective collaborations.
- Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.
- Initiative-taking, self-disciplined, and able to function independently as well as part of a team.
- Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.
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