San Francisco, California
Reporting to a Vice President of Regulatory Affairs, the Manager will support day-to-day regulatory activities of assigned projects. These include support of preparation and compilation of submissions for regulatory agencies, assigned clinical studies, management of regulatory submissions processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned.
- As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, supports clinical trial application activities, reviews and approves investigator document packages including FDA submissions, and manages other regulatory aspects of study as directed.
- Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments.
- Collaborates with Project Team representatives in planning of regulatory documents including responses to Health Authority queries. Supports processes by which regulatory submissions are reviewed, finalized, and signed-off.
- Manages tracking of regulatory/ethics submissions and approvals across all studies.
- Manages document archive processes.
- BA/BS degree in the biological or physical sciences preferred.
- Relevant pharmaceutical industry experience including experience in regulatory affairs. Minimum requirements are flexible, but 3 years minimum industry experience is generally required.
- Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices.
- Proficient in written, oral, and interpersonal communications in English.
- Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization.
- High attention to detail; ability to organize, prioritize, and delegate assigned projects.
- Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred.
- Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.