Senior Director, Regulatory Affairs

Verastem•Boston, MA

1d•Hybrid

About The Position

Assists Regulatory Leadership with the development and implementation of Regulatory strategy for timely development of investigational products and guide and assist in preparation of domestic and international registration dossiers. Interface with program and cross-functional teams to provide Verastem Regulatory input into development plans, provide solutions to development and regulatory barriers, and identify and manage potential risks. Act as primary company liaison to FDA and partner with CRO Regulatory lead supporting OUS development. In addition, assess and inform Management of new Regulatory activities that may impact the Corporation’s short and long-term plans. The Senior Director, Regulatory Affairs has foresight, is action oriented, a problem-solver, is a good communicator, and works well with internal cross-functional and external project teams.

Requirements

Advanced scientific degree (i.e., PhD, PharmD, MS) and 8+ years’ Industry-related experience in regulatory affairs and/or drug development experience
OR
Bachelor’s degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience
AND
Direct experience in clinical regulatory sciences
The Senior Director, Regulatory Affairs has significant experience preparing INDs and NDAs/BLAs, supporting CTA/CTNs, and having been directly involved in corresponding with U.S. (emphasis) and international health authorities.
The Senior Director, Regulatory Affair has experience in the pharmaceutical industry and an outstanding working understanding of the U.S. regulatory environment.
This position requires knowledge of U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH guidelines, and a familiarity with GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211).

Nice To Haves

Proven experiences and leadership assignments demonstrating leadership, effective communications with peers and company leadership, and effective conflict management skills.
Experience in regulatory submissions and regulatory interactions in the US, EU, and Japan
Direct experience in non-clinical and CMC regulatory sciences
Experience in Oncology
Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
Demonstrated ability to assess and manage risk in a highly regulated environment, attention to detail, negotiation and influence skills
Anticipated travel of 3-5 weekdays per month to the Verastem Corporate Office and occasional travel in support of face-to-face milestone development meetings with Regulatory Authorities.

Responsibilities

Develop, update and implement a global regulatory strategy which supports product (drugs, biologics and devices) development, registration, and lifecycle maintenance. Ensure the regulatory strategy is integrated into the development plan from candidate selection to end of product lifecycle. Develop and implement innovative approaches and solutions, and drive acceleration strategies. Identify and effectively communicate regulatory risks.
Maintain regulatory strategy documentation by using team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions.
Represent Verastem Regulatory in Regulatory Authority (RA) meetings. Lead and prepare internal cross-functional team for RA meeting including identification of topics, meeting request(s), briefing package, interact and negotiate with RA staff during the meeting, and communication to Company leadership describing outcome(s) and impact to the relevant development program.
Guide CMC, Nonclinical and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs.
Perform nonclinical and clinical GAP analyses of dossiers being considered for registration of products in the U.S.
Assist other Department staff in the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal departments (Manufacturing, QA/QC, Medical, etc.) to update investigational and commercial dossiers and labeling.
Work with third party contractors to ensure timely preparation and submission of electronic dossiers to health authorities.
Provide timely and effective communication updates to company leadership, program teams, cross-functional teams, and other internal stakeholders, as necessary, through effective written, spoken and/or presentation communications.
Provide regulatory direction in the development (or amendment) of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent.
Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans.
Partner with Advertising/Promotion Regulatory Scientist to advise the Brand Team on promotional strategy as necessary.
Partner with Corporate Communications reviewer to review and approve press materials and IR communications.
Coach and facilitate a feedback culture within the Verastem Regulatory Team to develop team performance and encourage an environment of shared learning.
This position requires a team and goal-oriented individual to interact with the various functional groups effectively.