POSITION SUMMARY:
This position will support global CMC regulatory activities related to investigational/commercial drug and biologic products. This position will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for preparation of global CMC regulatory submissions to achieve timely approvals. This position will also be responsible for leading the day-to-day activities of the Regulatory Affairs department and for managing various Regulatory Affairs personnel at the Director and Manager levels.
RESPONSIBILITIES:
- Accountable for strategy, planning, definition of content, and preparation of global regulatory eCTD CMC submissions and responses to Health Authority questions
- Identifies supporting documents required for global CMC submissions
- Prepares CMC briefing documents for meetings with regulatory agencies
- Participates in CMC meetings with regulatory agencies
- Directs CMC activities associated with global regulatory registration of drug and biologic products
- Provides CMC regulatory guidance and support to project core teams
- Provides CMC strategic support to investigational and commercial products
- Reviews CMC submission documents relative to regulatory guidance requirements
- Monitors, assesses, and maintains current awareness of evolving CMC regulations and guidance documents; apprises management of the impact of these changes.
- Manages direct reports, including recruitment, training, coaching, development, assignments, coordination of workload priorities, and performance
- Other activities as assigned
Required Skills
- Demonstration of positive interaction skills and work ethic
- Proven communication skills (verbal and written)
- Good organizational skills and attention to detail
- Capable of working independently and in a team environment
- Ability to manage multiple tasks simultaneously
- Ability to successfully negotiate in a team environment
- Good skills with MS Word, Excel, PowerPoint, and Document Management Systems
Required Experience
- S./B.A. required in Chemistry or Life Sciences; advanced degree preferred
- Minimum of 10 years of related experience in the pharmaceutical industry
- Specific experience related to the preparation of global regulatory eCTD CMC submissions for investigational and commercial products
- Prior regulatory affairs managerial experience, with direct supervision of mid- to senior-level regulatory professionals, or equivalent managerial role required