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.
- Provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
- Oversee preparation, review, and submission of regulatory documents maintaining compliance with regulatory requirements.
- Prepare regulatory agency meeting requests and briefing documents.
- Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
- 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) or special status (e.g. Orphan).
- Provide support for regulatory review of publications and clinical trial materials
- 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.
- At least 8+ years of experience in Regulatory Affairs related development of pharmaceuticals; preference for experience with small molecule development (Phase 1 through NDA and post-approval)
- Bachelor of Science in a scientific discipline, Masters preferred
- Excitement about the vision and mission of Sage and ability to work in a fast-paced environment
- Experience working with all levels of management and consulting with key business stakeholders.
- Strong team player that has a customer service approach and is solution oriented.
- Strong regulatory writing skills and knowledge of eCTD elements and structure
- Kean attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Strong written and verbal communication.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.