Dennis Partners

Develop global regulatory strategies for drug development programs, including a clinical-stage program for Parkinson’s disease and a companion diagnostic, along with pre-clinical programs.. Represent Regulatory Affairs on project teams & liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions.. A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry with at least 10 years of Regulatory experience with neurology programs.. In-depth understanding of the drug development, product commercialization and life cycle management processes.. Some experience with CMC Regulatory a plus, but not required.

regulatory affairs

This clinical-stage biotech company is developing precision medicines for genetically defined neurodegenerative and immunological diseases. 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 the company to get precision medicines approved. This company offers innovative science and a collaborative company culture. With their lead candidate going into Phase 2 trials this year, now an exciting time to join this growing organization! Responsibilities:<ul><li>Build and lead the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the company.</li><li>Develop global regulatory strategies for drug development programs, including a clinical-stage program for Parkinson’s disease and a companion diagnostic, along with pre-clinical programs.</li><li>Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings.</li><li>Provide input on development plans, Target Product Profile (TPP) development, risk assessments, resource planning, and other documents as required.</li><li>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</li><li>Represent Regulatory Affairs on project teams & liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions.</li><li>Ensure on-time, high-quality and regulatory–compliant submissions.</li><li>Lead regulatory meeting preparation efforts supported by the Project Team;</li><li>Hire and manage direct reports and consultants, as well as other duties as appropriate.</li><li>Provide key updates and guidance on Regulatory activities to Executive Team and Board of Directors, as needed.</li><li>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.</li><li>Build key infrastructure for Regulatory to support the development, approval, and launch of products.</li><li>Forecast budgets and develop department best practices and SOPs.</li></ul> Qualifications: <ul><li>Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.</li><li>A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry with at least 10 years of Regulatory experience with neurology programs.</li><li>Experience with Companion Diagnostics a plus, but not required.</li><li>A track record of successful interaction with FDA and other regulatory agencies.</li><li>Experience supporting both early and late phase development, including development and filing of associated regulatory submissions. Phase 2 experience highly desired.</li><li>Ability to review, understand and explain the regulations and guidance documents to guide project teams.</li><li>In-depth understanding of the drug development, product commercialization and life cycle management processes.</li><li>Ex-US or global regulatory experience highly desired.</li><li>Some experience with CMC Regulatory a plus, but not required.</li><li>Must be an experienced, hands-on-problem-solver who can develop a broad vision for a unique regulatory strategy.</li><li>Previous Regulatory team leadership desired.</li><li>Outstanding written, oral, organizational, and interpersonal skills.</li><li>Ability to collaborate effectively with internal and external key stakeholders.</li><li>Must be comfortable wearing many hats in a small biotech environment and have a “can do” attitude.</li></ul> This is a hybrid onsite position in the San Francisco Bay Area (2-3 days per week). NOTE: Our client prefers candidates in the SF Bay Area or elsewhere on the West Coast. The budgeted salary range for this position is $325,000 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.

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