This clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Senior Regulatory Affairs Consultant to oversee all regulatory activities and serve as the primary contact with FDA and other regulatory agencies. You will develop and implement regulatory strategies for their portfolio of oncology programs and lead Health Authority interactions. This engagement will be approximately 40 hours a week for 6-12 months, with potential to become a full-time Head of Regulatory position. Our client prefers someone on the West Coast who can come into their SF Bay Area office as needed.
Responsibilities:
- Serve as Acting Head of Regulatory Affairs for the company.
- 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, 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.
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 extensive Regulatory experience with oncology programs.
- Experience with biologics programs is highly desired.
- A track record of successful interaction with FDA and other regulatory agencies.
- Experience supporting mid and late phase development, including development and filing of associated regulatory submissions.
- Ex-US or global regulatory experience required.
- 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.
- Ability to drive meetings with various stakeholders including senior management, regulatory agencies, and project teams.
- 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.
Our client prefers candidates in the SF Bay Area or on the West Coast. All candidates must be authorized to work in the US. Visa sponsorship or transfers are not available for contract positions.