Executive Director, Regulatory Affairs

Organization Description 

We are a clinical-stage biopharmaceutical company dedicated to pioneering next-generation biotherapeutics, primarily focusing on cancer treatment. Our diverse therapeutic platforms and integrated drug development capabilities empower us to engineer highly differentiated product candidates. (Please note hiring for this role is supported by The Jule Group Talent Acquisition Firm) 

Why Join Us 

Our success hinges on the caliber of our team. We are driven by meaningful work that impacts both our colleagues and the patients we serve. We offer stimulating career opportunities, competitive benefits, and a culture that values and rewards excellence. 

Role Requirements 

This position, based in our Redwood City, CA office, operates on a hybrid model with a minimum of three days per week onsite. 

Key Responsibilities 

• Provide strategic regulatory leadership and guidance on projects, including regulatory strategies, requirements for clinical studies, and market approvals. 

• Develop and manage a high-performing regulatory team, emphasizing staff development and succession planning. 

• Utilize extensive regulatory knowledge to support corporate strategy and oversee global regulatory submissions. 

• Liaise with regulatory authorities worldwide, resolving key issues and expediting product approvals. 

• Stay informed about global regulatory changes and their impact on business and product development. 

• Collaborate with cross-functional stakeholders to achieve strategic business goals. 

• Manage regulatory budgets and processes, ensuring compliance and efficiency. 

Qualifications and Experience 

• Ph.D. with 10+ years of experience in pharmaceutical regulatory affairs, or B.S./M.S. with 12+ years in biotech or pharmaceutical regulatory affairs. 

• Preferred experience as a senior leader in Regulatory Affairs across multiple geographic areas, covering both small molecules and biologics. 

Core Competencies 

• Strong interpersonal skills for effective collaboration in global cross-functional teams. 

• Exceptional leadership abilities to manage and empower employees. 

• Comprehensive understanding of drug development processes and regulatory requirements. 

• Proven track record of regulatory accomplishments and strategic decision-making. 

• Excellent communication skills for conveying complex issues to internal and external stakeholders. 

Total Rewards 

We offer competitive salaries, generous benefits, a supportive work environment, and ample opportunities for professional growth. Our compensation packages are benchmarked against industry standards in our regions. 

Our Benefits Include 

• Competitive vacation and paid time off 

• Health and wellness benefits

• Paid time off for community volunteering 

• Pension savings program 

• Employee Share Purchase Program 

• Employee Equity Program 

• We are committed to diversity and equal opportunity employment.