General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for strategic regulatory activities related to SAGE’s clinical development programs.
Roles and Responsibilities
- As a member of the program teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
- 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.
- Organize and manage regulatory meetings with health authorities.
- Review materials for compliance with advertising and promotion regulations.
- Perform regulatory strategic assessments for new product candidates and new indications.
- 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).
- Manage contract staff and vendors as needed to support regulatory activities.
- Provide create and innovative solutions while being an advocate for compliance.
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 translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- 10-15 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
- Bachelor of Science in a scientific discipline, MS or PhD preferred
- Strong knowledge of eCTD elements and structure
- Strong regulatory writing skills and use of Microsoft WORD
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- 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.
- Possesses strong written and verbal communication skills.
- 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