Senior Manager, Regulatory Operations- Job ID: 1170ADN
The Regulatory Operations Senior Manager is responsible for assisting with the daily operational activities for regulatory submissions, timeline management and archival activities in accordance with agency requirements and company standards. The role of the Senior Manager will report directly to the Director of Regulatory Operations.
- Assist in managing daily operational activities for preparation of regulatory submissions (timeline management, scheduling, formatting, publishing, QC, archive and submission)
- Lead electronic publishing efforts in support of electronic submission of Investigational and Marketing applications to FDA and other ex-US regulatory agencies, as required.
- Collaborate with Regulatory Affairs and contributing functional areas to create submission project plans, trackers, and timelines for assigned projects.
- Prepare documents in all disciplines (e.g., CMC, nonclinical, clinical, and regulatory) to meet applicable standards for submissions in eCTD format and or paper submission, when required.
- Interface with publishing Vendors, as needed, to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies.
- Support the use of templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and training to cross-functional team members, as needed.
- Provide expertise in regulatory and technical submission requirements regarding submission preparation, format, and structure.
- Provide 1st tier support for Veeva RIM systems
- College degree and at least 6 years of experience performing directly relevant regulatory operations activities in the pharmaceutical and/or biotechnology industries, OR at least 8 years of experience performing directly relevant regulatory operations activities in the pharmaceutical and/or biotechnology industries.
- Thorough working knowledge of evolving technical requirements for electronic US, Canadian and EU Investigational and Marketing submissions.
- Strong communication, organizational, planning, and time-management skills.
- Detail-oriented with ability and desire to work in a fast paced, team oriented, small company environment, with the ability to manage simultaneous priorities and challenging deadlines.
- Advance proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project), Word Templates and publishing regulatory documents using Adobe Acrobat and ISI Toolbox. Prior experience with an EDMS required. Experience with using Veeva Vault RIM preferred.
- Ability to travel up to 5% of the time domestically and internationally
- New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
- Medical insurance
- Vision insurance
- Dental insurance
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance