Kelly® Science & Clinical is seeking a Senior Vice President of Regulatory Affairs for a fulltime, direct hire position with a pharmaceutical client in the San Francisco Bay Area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Overview:

Senior Vice President of Regulatory Affairs will lead our client’s regulatory strategies, ensuring compliance with global regulations and driving the safe and effective development of their innovative therapies. Working with the cross-functional development team, they will lead all Health Authority meetings associated with the program, hold accountability for the program’s global regulatory plan and its execution, identify and assess regulatory risks associated with planned clinical development activities, post-marketing safety surveillance, and provide technical advice and counsel. This is a critical leadership role within the company and has a significant influence on the achievement of corporate and program objectives and key results.

Reporting directly to the head of R&D, SVP will lead a team of regulatory and pharmacovigilance professionals. This is a full-time exempt role, with the ability to work remotely.

Key Duties & Responsibilities

Global Regulatory Affairs

• Lead the global regulatory strategy for the assigned product(s), in alignment with the overall corporate development plans and goals to support the successful development, registration, and commercialization of products across multiple markets with accountability for ensuring that plans meet global regulatory requirements.
  

• Lead Health Authority meeting planning, preparation, and conduct; accountable for the delivery of optimal meeting outcomes. Represent the company during meetings, discussions, and negotiations with regulatory agencies. Maintain positive relationships and effectively communicate the company’s regulatory strategy and positions.
  

• Ensure compliance with applicable regulatory requirements and guidelines, including but not limited to FDA (Food and Drug Administration), EMA (European Medicines Agency), and other global regulatory authorities. Monitor changes in regulations and proactively address any potential compliance issues.
  

• Proactively identify and assess regulatory risks associated with planned clinical development activities. Develop appropriate mitigation strategies and work closely with cross-functional teams to ensure risk assessments are integrated into product development and lifecycle management processes.
  

• Collaborate closely with cross-functional teams, including R&D, Clinical Operations, Quality Assurance, Legal, and Commercial teams, to ensure regulatory requirements are integrated into product development plans, clinical trials, and commercialization strategies.
  

• Develop and provide oversight of submission content for global dossiers, including INDs and CTAs outside the US. Coordinate with cross-functional teams to gather necessary data and documentation for timely and accurate submissions.
  

• Review and approve all submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, development safety update reports, and other documents as needed.
  

• Support strategy for providing submission of CMC and non-clinical information.
  

• Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications.
  

• Contribute to the development of target product profile and draft labeling.
  

• Stay updated on emerging regulations, global regulatory trends, guidelines, and best practices, and assess their impact on the company’s products and operations. Monitor competitor activities and regulatory landscape changes to anticipate potential impacts on the company’s products and regulatory strategies.

Pharmacovigilance and Risk Management

• Establish and maintain a robust pharmacovigilance system to monitor the safety of marketed products, including signal detection, assessment, and risk management strategies.
  

• Lead the preparation and submission of periodic safety reports (DSURs, PSURs, PADERs) to regulatory agencies.
  

• Collaborate with cross-functional teams to implement risk minimization and communication strategies.

Compliance and Training:

• Oversee the development and maintenance of regulatory policies, procedures, and standard operating procedures (SOPs) to ensure regulatory compliance across the organization.
  

• Conduct periodic audits and assessments to identify areas for improvement and implement corrective actions as needed.
  

• Stay current with evolving regulatory requirements and industry trends, ensuring the company’s compliance with global regulations.
  

• Provide training and education on regulatory and pharmacovigilance topics to internal stakeholders.

Team Leadership and Development:

• Recruit, mentor, and develop a high-performing regulatory and pharmacovigilance team.
  

• Provide leadership and guidance to the global regulatory affairs and pharmacovigilance team and foster a collaborative and innovative work environment that encourages continuous learning, professional growth, and excellence.
  

• Manage resources effectively to meet business objectives.
  

• Represent the company in relevant industry associations, conferences, and forums. Network with regulatory professionals and stay abreast of industry trends and best practices.

Qualifications:

1. Advanced degree in science (Ph.D., MD, JD, PharmD) in a relevant scientific discipline.
   

2. 15+ years of industry experience with a minimum of 10+ years of progressive leadership experience in regulatory affairs and pharmacovigilance within the biotechnology or pharmaceutical industry. Experience and expertise in developing regulatory strategies leading to significant clinical development progress.
   

3. Demonstrated ability to work independently and handle multiple priorities within timelines.
   

4. Demonstrated success in working in a matrix team and collaborating cross-functionally with clinical development, clinical operations, commercial, technical operations, pharm/tox, and medical affairs to resolve issues and improve efficiency.
   

5. Significant experience w/US FDA regulations; strong understanding of Global Health Authority policies, laws, regulations, and guidelines as they apply to global drug development, approvals, and pharmacovigilance.
   

6. Significant knowledge of the drug development process (early stage through commercialization).
   

7. Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management.
   

8. Demonstrated ability to prepare for launch readiness / ensuring launch readiness.
   

9. Effective communication skills that allow for teamwork, collaboration, and open dialogue cross-functionally (verbal/written/email/presentation) are required. Need to speak with ease, confidence, and have an ability to come well-prepared and solution-focused with (to??) all levels of the leadership team.
   

10. Ability to communicate regulatory strategy to key stakeholders at all levels of the organization is vital to the success of the role.
    

11. Ability to travel up to 10% (US and International).

9653210