ABOUT THE ROLEReporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
KEY RESPONSIBILITIES- Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
- Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks
- Manage coordination, preparation, and timely submission of regulatory documents and filings
- Review global regulatory submissions for consistency and quality across regions
- Manage preparation of responses to queries from regulatory authorities
- Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
- Ensure conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
- Provide regulatory advice to other functional areas
- Participate in regulatory due diligence activities
Relationships- Build and maintain collaborative relationships with external business partners to achieve project regulatory goals
- Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
- Develop and manage relationships with external vendors and regulatory health authorities
- Manage activities for meetings and conferences with FDA, EMA, and other regulatory authorities
Management- May supervise employees and consultants/contractors in Regulatory Affairs
- Develop and implement regulatory operating guidelines and common work practices/strategies within the team
QUALIFICATIONS- Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus
- 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry strongly preferred; experience in cardiometabolic/cardiovascular or endocrinology therapeutic areas is a plus
- Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
- Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
- Solid working knowledge of core processes: discovery, development, and manufacturing
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions and processes is a strong plus
- Ability to work effectively across teams, functions and with outside partners
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
PAY RANGEThe salary range for this role is $180,000 - $195,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
