San Francisco, CA
about 1 month ago
Director Regulatory Affairs- San Francisco, CA
Specific Responsibilities and skills for Position
- Leads all regulatory activities in line with regional requirements and company policies
- Prepares submissions and leads teams in preparation of submissions that require collaboration with other teams
- Responsible for ensuring accurate submission of all regulatory documents needed to receive clinical trial applications and marketing authorizations for assigned product(s) and territories.
- Ensures preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
- Responsible for updating product packaging and associated information is maintained in accordance with the product license.
- Represents Regulatory Function at internal meetings and works to create relationships with local Regulatory Authorities.
- 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.
- Responsible for leading one or more teams in preparation of submissions and maintenance of licenses.
- Is recognized as an expert resource for Regulatory Advice in other departments.
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