General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a role responsible for all aspects of Regulatory Operations including submission project management.
Roles and Responsibilities
- Publication and submission of electronic submissions (and paper submissions, when required) to regulatory agencies to support the conduct of clinical trials and marketing authorizations, primarily for the U.S.
- Submission of promotion, advertising and labeling materials to The Office of Prescription Drug Promotion (OPDP) to support commercial activities
- Create and maintain archives of communications with Health Authorities
- Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements
- Support regulatory documentation users and contributors
- Leads assigned projects with manageable risks and resource requirements
- Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH regulations.
- Acts as submissions representative on local and global project teams; provides resource and timeline estimates for regulatory submissions, as well as technical submissions expertise, as needed.
- Develops and maintains best practices for the Submissions Group consistent with evolving FDA guidelines for electronic submissions.
- Provides support to Regulatory Affairs and other project stakeholders in the creation of submissions documents
- Position has direct impact on the company's ability to meet goals and timelines related to regulatory submissions. Identifies and escalates issues which may impact submission timelines and goals.
- Assists the regulatory affairs liaisons in the determination of submission strategy.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, excellent analytical skills and an ability to communicate issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- BA/BS degree or equivalent experience
- 3-5+ years of Regulatory Operations experience in a biotech/pharmaceutical industry including 2+ years experience with submission of promotion, advertising and labeling material to OPDP.
- Extensive experience with Microsoft Word, Adobe Acrobat, and electronic publishing software. Experience with Starting Point templates preferred
- Experience using electronic document management systems.
- Thorough current knowledge of CTD/eCTD format and regulatory submission requirements
- Experience compiling IND, NDA, and other CTD submissions
- Strong attention to detail and the ability to manage multiple tasks
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Strong communication skills and ability to work independently.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage