Department: Regulatory Affairs
Job Title: Senior Manager/ Associate Director, Regulatory Affairs
Job Location: South San Francisco, CA
The Regulatory Affairs Professional (Sr. Manager / Associate Director) will be responsible for the comprehensive management of regulatory aspects of the company’s marketed product antibiotic Vibativ® (telavancin). This position will also allow for key contribution to department and company-initiatives related to regulatory affairs operations and strategy.
Major Duties & Responsibilities:
• Responsible for regulatory review, approval, and submission of all US Promotional materials to the FDA Office of Prescription Drug Promotion (OPDP). A key cross-functional responsibility of this position includes management of the cross-functional Promotional Material Review process.
• Responsible for management of changes to US labeling and collaboration with partners on labeling and responses supporting initial registration and communications regarding any changes to core and/or US labeling. Responsible for providing input from the company on any labeling changes requested by a Regulatory Health Authority.
• Provide regulatory support for Chemistry, Manufacturing and Controls (CMC) changes in the US and CMC regulatory support to partners for international registration and subsequent CMC changes.
• Responsible for supporting the company’s fulfillment of postmarketing commitments and requirements, including the established Risk Evaluation and Mitigation Strategy (REMS)
• Serve as regulatory lead on the Pediatric Clinical Development Program.
• Contribute as the regulatory lead on the company’s international, Phase 3 Clinical Development Program in Bacteremia.
• Responsible for timely, high-quality, US regulatory submissions (IND/NDA) in the eCTD format
• Serve as primary contact with corporate partners in support of communications with international Health Authorities
• Please note: Theravance has a broad and emergent product pipeline, and future assignments to other late-stage and early stage development teams will be likely based upon the individual candidate and company need.
o Minimum Bachelor’s degree; studies in science and advanced degree desirable
• Specialized knowledge that would be desirable and supportive of success in this position includes:
o Experience working on promotional materials and with OPDP (formerly DDMAC).
o Experience with US and international management of post-marketing CMC changes
o Experience in pediatric drug development and understanding of US and EU regulations related to pediatric requirements
o Experience in the management of core labeling and/or US labeling
o Understanding of regulatory requirements for and experience with submission of applications (IND / NDA) in eCTD format
o Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
o Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
o Approx. 10 years progressive Regulatory Affairs experience for Associate Director level; minimum 5 years Regulatory Affairs experience for Senior Manager