Job Description

We are seeking an experienced Regulatory Affairs professional to build the regulatory group at Synlogic, a clinical-stage biotech company with multiple product candidates in various stages of development. The successful candidate will provide expertise in translating clinical, nonclinical and CMC regulatory requirements into creative regulatory plans in a new therapeutic modality where little formal guidance exists. He/She will be expected to work collaboratively with global regulatory agencies to define suitable path towards commercialization for a pipeline of product candidates. Primary responsibilities include strategic planning, preparation of critical submission documentation, communication and participation in meetings with FDA and other regulatory authorities.

Duties and Responsibilities

  • Develops and implements strategies to facilitate the progress of compounds into clinical trials and through to registration.
  • Serves as regulatory representative on selected project teams.
  • Serves as regulatory liaison with partner(s), the FDA and other regulatory agencies.
  • Reviews technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments.
  • Recommends regulatory policies to assure adherence to FDA and EMA requirements.
  • Schedules and tracks project specific and operational activities relating to the regulatory department.
  • Keeps abreast of all pertinent laws, regulations and guidances, and provides insight on current regulations and guidance documents relevant to product development projects; provides subsequent recommendations for regional regulatory strategies and implementation activities.
  • Works with Quality Assurance to provide regulatory expertise and policy support for good pharmaceutical practices (GCPs, GMPs, and GLPs).
  • Contributes to the modification, development and implementation of Company practices and policies related to regulatory affairs.
  • Prepares Regulatory Standard Operating Procedures and provides regulatory review of SOPs from other departments, as necessary
  • Provides oversight of internal regulatory affairs staff as well as any contractors, consultants and vendors

Job Requirements

  • Bachelors or Masters in a life science or relevant discipline.
  • Minimum eight years of broad regulatory experience including a focus on regulatory strategy.
  • Demonstrated ability to interface with cross-functional teams as well as regulatory agencies.
  • Experience with Phase 1 through product registration in global setting.
  • Excellent writing and interpretive skills.
  • Experience with CMC regulations preferred.
  • Proficiency in strategizing, planning, monitoring and problem solving.
  • Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly.
  • Ability to manage multiple and diverse issues.
  • Strong facilitation, organizational, analytical and time management skills.
  • Ability to apply knowledge to new situations and to dig into new areas of science and medicine.
  • Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement.


Occasional travel required


To apply for this position please send your resume to:

Synlogic, Inc. is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.