San Francisco, CA, USA
about 1 year ago
My client is a highly innovative and rapidly growing biopharmaceutical company that specializes in developing Endocrinology therapeutic products. My client is looking to hire a Regulatory Affairs Operations Manager to maintain the daily operational activities for the regulatory submissions while working closely with the Director of Regulatory Affairs Operations.
This person will:
- Manage daily operational activities for preparation of regulatory submissions, including project and timeline management, resource 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, for example CMC, nonclinical, clinical, and regulatory, to meet applicable standards for submissions in eCTD format and or paper submission, when required
- Interface with publishing Vendors 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, advice and training to cross-functional team members, as needed.
-Provide expertise in regulatory and technical submission requirements with regard to submission preparation, format, and structure
This person will have:
- BS degree in a scientific or technical discipline and at least 5 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 regulatory submissions, including NDA submissions
- Strong communication, organizational, planning, and management skills
- Detail-oriented with ability and desire to work in a fast paced, team oriented, small company environment where the ability to manage simultaneous priorities and challenging deadlines
- Advance proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project), and publishing regulatory documents using Adobe Acrobat and ISI Toolbox. Prior experience with an EDMS required. Experience with Veeva Vault Regulatory systems preferred
- Ability to travel up to 5% of the time domestically and internationally