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Sage Therapeutics Associate Director, Regulatory Affairs in Cambridge, Massachusetts

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.

Basic Qualifications:

  • 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)

Preferred Qualifications:

  • 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.

Employment Type:

Employee

Number of Openings:

1

Job ID:

R000591

#Biotechnology #Careers #ThisIsSage

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.

EEO is the Law (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law - Poster Supplement

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.

Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy

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