Manager / Senior Manager, Regulatory Operations
Reporting to the Vice President, Regulatory Affairs, the Manager / Senior Manager, Regulatory Operations, will manage the global regulatory operational activities for the company. In coordination with internal staff and external consultants/contractors, the Manager / Senior Manager, Regulatory Operations is responsible to provide strategic regulatory operational guidance to project teams during development, submission/approval processes, and commercialization of products. Coordinate and execute the regulatory submission management process including, formatting, publishing, submission, and archiving of electronic documents provided to regulatory authorities. Manages the operational aspects of eCTD filings, OPDP submissions, and shares Regulatory guidance and training related to submission requirements for the broader Regulatory Affairs Group. May also be responsible for vendor and supplier proposals and bid negotiation for regulatory operations services and resources. Ability to operate effectively in a fast-paced environment.
- Plan, compile, publish and submit Regulatory documents for IND, NDA and other applications, including initial submissions, amendments, and meeting materials to the FDA or other Regulatory Authorities.
- Work closely with regulatory affairs broader team to provide operational oversight and support in the preparation and implementation of the regulatory strategic and operational plans to support efficient development and pathway to global registrations.
- Assist with development and submission of high-quality regulatory documents (eg INDs, CTAs, Amendments, Orphan Drug Applications, Pediatric Study Plans, Regulatory Designation Requests, Special Protocol Assessment requests, Labeling, Marketing Applications, and Responses to Health Authority questions)
- Serve as the Regulatory Operations lead, collaborating within Regulatory Affairs, and the cross-functional project team to develop and implement submission strategies and timelines
- Assure all electronic submissions are in compliance with regulatory requirements and ICH eCTD specifications
- Oversees creation and management of submission content plans
- Create processes and standard requirements to support all submission related activity to ensure that the company meets all key submission milestones
- Participates in the evaluation, selection, validation (as applicable) and implementation of technology and equipment related to submission planning, preparation, assembly, dispatch, and/or archiving
- Support the development and implementation of ENNOV platform
- Creates, updates and maintains submission templates as needed
- Provide input on or write processes and SOPs in relation to regulatory operations or multifunctional procedures for submissions
- Liaise with and oversees vendors
- May manage other document specialist personnel
- Maintain regulatory systems and tools, such as shared drives, etc.
- BA/BS degree or equivalent experience; RAC designation is a plus
- 2-4 years of Regulatory Operations experience in the biotech/pharmaceutical industry
- Experience using or supporting electronic document management systems
- Proficient with publishing tools/eCTD software, EDMS, MS Word, Word templates, Adobe Acrobat, SharePoint and standard Office tools.
- ENNOV platform experience, highly desired
- Thorough current knowledge of CTD/eCTD format and regulatory submission requirements
- Experience compiling IND, NDA, and other submissions, highly desired
- Strong attention to detail and the ability to manage multiple tasks
- The ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
Equal Employment Opportunity/M/F/disability/protected veteran status