This clinical-stage biotech company is enabling cures by targeting mast cells and stem cells. They are seeking a VP or SVP of Regulatory Affairs to oversee all regulatory activities and serve as the primary contact with global regulatory agencies. You will create, develop and implement regulatory strategies, manage global submissions, and oversee a small Regulatory team. This company offers a collaborative and fun company culture, flexible work arrangements, and unlimited paid time off. With multiple programs in clinical trials, now an exciting time to join this growing organization!
Responsibilities:
- Build, lead, and manage the global Regulatory Affairs function to ensure adherence to appropriate regulations and standards.
- Provide strategic direction to all Regulatory functions including hiring, mentoring, and leading staff.
- Build key infrastructure for Regulatory and Quality compliance to support the development, approval and commercial launch of products.
- Guide and/or lead regulatory agency interactions, including communications and meetings.
- Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program.
- Provide key updates and guidance on Regulatory activities to Executive Team and Board of Directors, as needed.
- Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world.
- Direct and negotiate submissions (IND, CTA, BLA, MAA etc.) and approvals with Regulatory authorities.
- Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals. Ensure on-time, high-quality and regulatory–compliant submissions.
- Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
- 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.
Qualifications:
- Advanced degree such as MS, PharmD, or PhD preferred.
- A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry.
- Strong understanding of the drug development process; Experience in biologics development and regulations is highly preferred.
- A track record of successful interaction with FDA and other regulatory agencies, as demonstrated by timely submissions and approvals of biological/pharmaceutical/biotech compounds.
- Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
- Ability to review, understand and explain the regulations and guidance documents to guide project teams.
- Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world.
- Must have experience working with EU/EMA.
- Ability to drive meetings with various stakeholders including senior management, regulatory agencies, investors, expert advisors, collaborators and project teams.
- Must have previous Regulatory team leadership experience.
- Outstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role.
- Ability to collaborate effectively with internal and external key stakeholders.
- Strong relationship management and interpersonal skills to quickly gain confidence both with internal stakeholders and externally among regulatory agencies.
- Ability to influence strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
- Excellent organizational and project management skills and ability to think strategically.
- Outstanding presentation, written and oral communication skills required. Must be a clear communicator who can influence effectively both internally and externally.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
NOTE: Our client prefers candidates in the SF Bay Area only. This is a hybrid/onsite position.
The budgeted salary range for this position is $325,000 to $400,000 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.