San Francisco, CA
2 months ago
Senior Director Regulatory Affairs- San Francisco, CA
Specific Responsibilities and skills for Position
- Leads all regulatory activities in line with regional requirements and company policies
- Develops global regulatory strategies, recognizes and offers strategies to mitigate risks and influences project teams.
- Prepares submissions and leads teams in preparation of submissions that require collaboration with other teams
- Ensures knowledge of regulatory requirements are up to date, provides new regulatory guidance when possible, and conveys changes in regulatory information to project and management teams.
- Obtains an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
- Responsible for creation and implementation of regulatory strategies and overseeing negotiations with regulatory bodies.
- Represents Regulatory Function at internal meetings and builds strong relationships with local Regulatory Authorities.
- Reviews complex technical documents and influences colleagues across functions
- Schedules and arranges own activities and those of direct reports.
Knowledge, Experience and Skills
- Advanced Science Degree preferred (PhD, PharmD, MD, MSc)
- 12+ years of overall regulatory experience
- Global regulatory lead experience required
- Management experience required
- Experience in inflammation, rheumatology, immunology, or dermatology required