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.
Provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
Oversee the 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 creative 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. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a 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.
5+ years of experience in Regulatory Affairs related to the development of pharmaceuticals.
Bachelor of Science degree in a scientific discipline.
Experience with small molecule development (Phase 1 through NDA and post-approval).
Strong regulatory writing skills and knowledge of eCTD elements and structure.
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, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
Number of Openings:1
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All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.#LI-Remote