Careers

Job Description

Abide Therapeutics is seeking an Director of Regulatory Affairs, to contribute to the development of novel small-molecule drugs targeting the serine hydrolase enzyme family. Abide’s mission is to develop innovative medicines that target serine hydrolases, one of the largest enzyme classes in nature with validated, but mostly untapped therapeutic potential. Abide is a privately held biotechnology company. This position will be based at our Princeton, NJ location.

If you thrive in a dynamic, fast-paced environment and enjoy creative and challenging work, Abide may be the company for you. 

The successful candidate will be responsible for providing regulatory leadership for Abide’s early stage development programs and will:

  • Develop US and EU regulatory strategies for clinical development programs.
  • Participate on cross-functional project teams, providing regulatory expertise and input into drug development strategy, planning, and execution. 
  • Plan, write, and review drug applications, amendments, annual reports, and other submissions.
  • Ensure timely submission of regulatory documents e.g. CTAs/INDs directly or through a partner (e.g. CRO)
  • Lead interactions with health authorities and respond to agency queries.
  • Ensure that all documents are filed and archived properly in accordance with SOPs and regulatory agency requirements.
  • Keep executive leadership and project teams informed of current FDA and EMEA guidelines or other (inter) national guidelines pertaining to Regulatory Affairs.

In addition, the successful candidate will be willing to take on adjacent responsibilities as needed and based upon candidate’s specific background.

Experience and education requirements:

  • MS, PhD, PharmD, MD, DO or comparable degree preferred.
  • Ten or more years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.
  • Experience with all phases of clinical development.
  • Experience preparing pre-IND and IND documentation is required.
  • Must have experience working on CNS programs.
  • Strong working knowledge of US FDA regulations; global experience a plus.
  • Experience working directly with the FDA is required.
  • Excellent time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
  • Excellent written and verbal communication skills and interpersonal skills.
  • Both an effective team player and strong individual contributor, flexible, and able to handle changing priorities, multiple tasks and deliver high quality results under tight timeline.
  • Ability to manage ambiguity in a small, start-up environment.
  • Passion, humility, and excitement for doing whatever it takes to drive research forward.


For additional information about Abide please visit our website at www.abidetx.com.  In addition to a competitive compensation package with stock options, Abide also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) Plan.  For consideration, please submit your resume and cover letter referencing job DR2018.08.08 to jobs@abidetx.com.  Abide is an EEO employer.

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