Associate Director, Regulatory Affairs
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a role that is responsible for regulatory activities related to SAGE’s clinical development programs.
Roles and Responsibilities
- Develop regulatory strategy and submission plans for quality and timely filings.
- As a member of study teams, provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development, registration, and post marketing activities of pharmaceuticals.
- Compile, review, approve and submit clinical trial (e.g. IND, CTA), marketing registration (e.g. NDA, MAA), and post marketing applications, amendments, and supplements.
- Prepare regulatory agency meeting requests and briefing documents.
- Develop and provide strategic guidance for pediatric submissions (e.g. PSP, PPSR, PIP)
- Assist or lead in activities related to approved product labeling
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Support the organization and record regulatory meetings with health authorities.
- Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority, Expanded Access) or special status (e.g. Orphan).
- Manage contract staff and vendors as needed to support regulatory activities.
- Provide create and innovative solutions while being an advocate for compliance.
- Assist with SOP generation.
- Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
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, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to operationalize complex regulatory strategies. Ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Bachelor of Science in a scientific discipline
- 5+ years of experience in Regulatory Affairs related to development of investigational pharmaceuticals (Phase 1 through Phase 3)
- eCTD elements and structure experience
- Possess strong written and verbal communication skills, including advanced regulatory writing skills
- Advanced knowledge of the Microsoft suite of tools including Word, Powerpoint, etc.
- Experience working with all levels of management and consulting with key business stakeholders.
- Ability to work successfully with cross-functional teams as well as with external partners and vendors.
- Ability to influence appropriate plans and actions.
- 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 and ability to work in a fast-paced environment.
Learn more here
Job posted: 2021-03-22