General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, strategic thinker for the role of Manager, Regulatory Operations. In this position, you will support multiple areas of Regulatory Operations, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault Regulatory Information Management system, submission management, and training of associated business processes. The Manager, Regulatory Operations will be part of a dynamic and evolving Regulatory Operations team and must support the overall vision for Regulatory Information Management at Sage. The candidate must also be excited about Sage's mission and vision, as well as Sage's Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Roles and Responsibilities
Oversee data collation/governance activities to ensure information quality in Vault RIM.
Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM.
Manage user groups and workflows and create and maintain archives of Health Authority interactions.
Develop, manage, and distribute reports, dashboards, and templates to meet user needs.
Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management.
Provide Tier 1 support for end users and escalate issues to IT.
Facilitate meetings with decision makers to discuss issues and ensure alignment.
Interact with end users to understand evolving requirements and work with RIM team to map requirements to RIM program roadmap.
Partner with IT and Quality to support system validation activities.
Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM.
Participate in data migration and impact analysis activities, as needed.
Interact with other Vault Business Process Owners across Sage to improve processes and align where necessary.
Serve as primary contact for Health Authority correspondence/submission archives and perform document management/tracking related to archival.
Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, NDA, etc.).
Coordinate and track delivery of required submission content from content/document owners.
Manage timelines for submission deliverables and reviews in accordance with program/corporate objectives.
Publish and submit regulatory submissions 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, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations.
BA/BS degree or equivalent experience.
4+ years of regulatory operations experience in the biotech/pharmaceutical industry.
6+ years of regulatory operations experience in the biotech/pharmaceutical industry.
Strong understanding of regulatory processes as they relate to RIM and document management.
Hands-on experience with Vault RIM.
Vault RIM implementation and training experience.
Effective communication skills, both verbal and written.
Experience with Microsoft Word, StartingPoint Templates, ISI/TRS/DXC Toolbox, Adobe Acrobat, and electronic publishing software (ARIM/RIM Smart preferred).
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.
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.
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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
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