Sr Director, Regulatory Affairs CMC

Sage Therapeutics Cambridge , MA 02138

Posted 2 months ago

Reports to:

Senior Vice President, Regulatory Affairs

Direct Reports:

Position will currently manage one Associate Director plus 1-2 consultants and will be responsible for designing and growing a CMC team as needed

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as Head of Regulatory CMC. As the leader of Regulatory CMC, overall responsibility for regulatory CMC activities supporting the development and commercialization of Sage's products, with a focus on developing and implementing CMC regulatory strategies. Will need to work collaboratively with cross-functional partners to develop and implement strategies to support product approval in a dynamic fast-paced environment.

Roles and Responsibilities (Essential Functions)

  • Preparation and review of CTD Module 3, QOS and other CMC documents in support of regulatory filings

  • Regulatory review and approval of cGMP documentation

  • Regulatory CMC Lead for regulatory interactions

  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports

  • Act as primary regulatory representative at internal meetings, such as governance meetings, as well as at meetings with business partners and regulatory agencies for all CMC related issues

  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines

  • Mentor and establish development plans for Regulatory CMC staff in addition to managing contract staff

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, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations

Basic Qualifications

  • 10+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, CNS experience preferred

  • Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred

Preferred Qualifications

  • Established working knowledge of regulatory guidelines and regulations (US and international).

  • Regulatory experience working on small molecule drug development programs.

  • Strong knowledge of eCTD elements and structure and regulatory writing skills.

  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

  • Strong team player that 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 and presentation 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.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

Employment Type:


Number of Openings:


Job ID:


#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

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Regulatory Affairs

Editas Medicine

Posted Today

VIEW JOBS 11/27/2020 12:00:00 AM 2021-02-25T00:00 <p>What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases.</p><p>We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.</p><p>Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.</p><p>Key Responsibilities</p> <ul> <li>Develop and implement global regulatory strategy for the company’s gene editing programs </li> <li>Represent the regulatory function on cross-functional product development teams. Provide innovative strategic and tactical advice to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements</li> <li>Plan, prepare, and manage global submissions to regulatory authorities including INDs, CTAs, and registrational dossiers</li> <li>Lead regulatory interactions with health authorities including managing preparation of briefing documents</li> <li>Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs and senior management, as relevant</li> <li>Ensure that regulatory documents are accurate, complete and verifiable to confirm compliance with regulatory requirements</li> <li>Keep abreast of relevant global regulatory requirements and keep the company informed of changes and consequences</li> <li>Oversee vendor responsibility for regulatory activities and submissions as needed.</li> </ul><p><strong>Requirements</strong></p><p>Minimum Qualifications</p> <ul> <li>Bachelor’s degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 8+ years’ experience in drug development/regulatory affairs. </li> <li>Experience with both US FDA and EMA is required. Global experience is preferred. </li> <li>Prior BLA and NDA experience is preferred. </li> <li>Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy preferred</li> </ul><p>Critical Capabilities </p><ul> <li>A broad understanding of the drug product development process is required. </li> <li>This position requires a thorough knowledge of U.S. Federal Regulations, ICH Guidances, and relevant FDA and EMA guidances.</li> <li>Proven experience in critically reviewing detailed scientific information and providing assessment of technical arguments and conclusions based on the data</li> <li>Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.</li> </ul> Editas Medicine Cambridge MA

Sr Director, Regulatory Affairs CMC

Sage Therapeutics