This clinical-stage biotech company is developing small molecule therapeutics for the treatment of devastating cancers and immune disorders. They are seeking a Vice President of Regulatory Affairs to develop and lead global regulatory strategies for their portfolio of programs and serve as the primary contact with health authorities. You will provide crucial input to the organization to advance the pipeline and help them to get new drugs approved. This company offers a collaborative, science-driven culture and flexible work arrangements. With multiple programs in clinical trials and a rapidly growing clinical portfolio, now is an exciting time to join this growing organization!
Responsibilities:
Develop and lead regulatory strategies for a portfolio of oncology and immunology programs.
Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings.
Coordinate and manage regulatory submissions (e.g. INDs, clinical trial applications, marketing applications) in collaboration with multi-disciplinary development teams as well as senior management
Represent Regulatory Affairs on project teams & liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions.
Ensure on-time, high-quality and regulatory-compliant submissions.
Lead Regulatory meeting preparation efforts supported by the Project Team;
Build and lead the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the company.
Hire and manage direct reports and consultants, as well as other duties as appropriate.
Provide key updates and guidance on Regulatory activities to Executive Team and Board of Directors, as needed.
Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of Regulatory project plans throughout the life cycle.
Build key infrastructure for Regulatory to support the development, approval, and launch of products.
Forecast budgets and develop department best practices and SOPs.
Serve as a member on the company's R&D Leadership team.
Qualifications:
Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.
A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry.
Must have Regulatory experience with oncology and also non-oncology therapeutic areas.
Experience with immunology programs a plus.
A track record of successful interaction with FDA and other regulatory agencies.
Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
Must have both US and ex-US regulatory background.
Ability to review, understand and explain the regulations and guidance documents to guide project teams.
In-depth understanding of the drug development, product commercialization and life cycle management processes.
Must be an experienced, hands-on-problem-solver who can develop a broad vision for a unique regulatory strategy.
Leadership, Interpersonal and Soft Skills:
Previous Regulatory team leadership desired.
Outstanding written, oral, organizational, and interpersonal skills.
Ability to collaborate effectively with internal and external key stakeholders.
Must be comfortable wearing many hats in a small biotech environment.
This is a hybrid position in the San Diego Area. NOTE: Our client prefers candidates in California or elsewhere on the West Coast. Local candidates in the San Diego Area will be onsite 2-3 days a week. Candidates outside of San Diego will be expected to be in the office at least once per month.
The budgeted salary range for this position is $320,000 to $360,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.