- Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the company.
- Develop and execute innovative Regulatory strategies for a portfolio of oncology programs to ensure success.
- Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings.
- Direct and negotiate submissions (IND, CTA, NDA, BLA, MAA, etc.) 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 strategic direction to all Regulatory functions including hiring, mentoring, and leading staff.
- 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.
- 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.
- Build key infrastructure for Regulatory to support the development, approval, and commercial launch of products.
- Forecast budgets and develop department best practices and SOPs.
- 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 extensive Regulatory experience with oncology programs. Experience with biologics programs is 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.
- Ability to review, understand and explain the regulations and guidance documents to guide project teams.
- Experience filing successful marketing applications (NDA, BLA or MAA). Prior successful drug approvals a plus.
- Experience with Orphan Drug Designations, Fast Track, Accelerated Approval, Breakthrough Therapy, and/or Priority Review protocols.
- In-depth understanding of the drug development, product commercialization and life cycle management processes.
- Ex-US or global regulatory experience highly desired.
- Ability to drive meetings with various stakeholders including senior management, regulatory agencies, and project teams.
- Previous Regulatory team leadership experience highly desired.
- Outstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role.
- Ability to collaborate effectively with internal and external key stakeholders.
- 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.
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Vice President of Regulatory Affairs - California, United States - Dennis Partners
3 weeks ago
Description
This clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. You will develop and implement regulatory strategies, lead Health Authority interactions, and oversee a small and potentially growing Regulatory team. This company offers innovative science, a collaborative and fun company culture, and flexible work arrangements. With multiple programs in going into clinical trials, now an exciting time to join this growing organization
Responsibilities:
Qualifications:
This is an onsite position in the San Francisco Bay Area (2-3 days per week). NOTE: Our client prefers candidates in the SF Bay Area or on the West Coast, but other remote candidates may be considered.
The budgeted salary range for this position is $300,000 to $350,000 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.
