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Senior Director, Regulatory Affairs

Sage Therapeutics
Working from Home
Start date
Nov 7, 2023

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Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time

Job Details

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as Sr. Director, Regulatory Affairs to provide strategic expertise in regulatory processes, laws, and regulations. The candidate will be responsible for creating regulatory development plans and for successful execution against those plans. To be successful in this role the individual will be self-motivated and must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.

Roles and Responsibilities

  • As a regulatory lead on program core teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.

  • Identify issues and proactively provide strategies to address them, communicating to the program team, Regulatory leadership and Company management.

  • Compile, review, approve and submit clinical trial (IND, CTA) and marketing registration applications (NDA, MAA), managing submission timelines in collaboration with cross functional teams.

  • Lead, organize and manage regulatory correspondence and interactions, including interactive meetings with health authorities attended by team members and senior leaders of both the Company and the health authority.

  • Develop and create regulatory strategies consistent with program objectives

  • 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).

  • Perform regulatory strategic assessments for new product candidates and new indications.

  • Manage staff, contractors and vendors as needed to support regulatory activities.

  • Provide creative and innovative solutions while being an advocate for compliance.

  • Ensuring compliance with applicable laws and regulations related to our product development and marketing activities.

  • Create regulatory submission timelines in collaboration with cross functional teams.

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 identify issues and raise to key stakeholders in order 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.

Basic Qualifications

  • B.S. in a scientific discipline required

  • Must have 10+ years pharmaceutical industry experience in regulatory affairs

Preferred Qualifications

  • Advanced degree

  • Fast-track or breakthrough experience

  • Experience with small molecule development (Phase 1 through NDA and post-approval).

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

  • Labeling and REMS development experience

  • Excellent organizational and communication skills, both written and verbal

  • Ability to work independently as well as part of a team environment

  • Proven ability to manage multiple projects, identify and resolve regulatory issues

  • Strong interpersonal skills and the ability to effectively work with others

  • Ability to influence without authority, lead change and manage resistance to change.

  • Must be able to solicit information, persuade others and shape outcomes.

  • Demonstrated strong scientific reputation as evidenced by strong publication record.

  • 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.

Benefits and Compensation The base salary hiring range for this position is $215,718 - $296,612.*
  • The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
  • This position is eligible to participate in the Companys annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
  • To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.
*Base salary ranges are periodically reviewed and subject to change. #LI-Remote


Welcome To The Workplace With A Difference

Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.

At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.

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Company info
215 First Street
United States

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