Senior Regulatory Affairs Manager

R&D Partners is seeking to hire a Senior Regulatory Affairs Manager in the San Francisco Bay Area.

This is a hybrid role typically requiring on-site presence at least 2 days per week.

Your main responsibilities as a Senior Regulatory Affairs Manager:

• Lead, communicate and execute global clinical and nonclinical regulatory strategies throughout a program’s lifecycle
• Key liaison with Health Authorities and lead the preparation of nonclinical / clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities
• Provide strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
• Lead planning and preparation of the clinical and nonclinical strategy and content for global Health Authority (HA) meetings, working closely with SMEs and regional regulatory leads
• Oversee any CRO/vendors that are contracted to perform regulatory activities related regulatory submissions and HA interactions
• Serve as lead on Market Applications (MA) Filing Team to support global MA preparation, submission, review through approvals

What we are looking for in a Senior Regulatory Affairs Manager:

• PhD with 6+ years of Nonclinical or Clinical Regulatory Affairs experience preferred
• Masters or Bachelor’s degree with 8+ years of Nonclinical or Clinical Regulatory Affairs experience
• Demonstrated experience in developing strong relationships with internal and external stakeholders
• Strong communication skills, with the ability to translate complex concepts into actionable insights
• Self-motivated, adaptable, and effective in fast-paced, evolving environments

Why choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Salary:

• $155,000 to $168,000 (Dependent on Experience)

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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