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Manager, Regulatory Affairs

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role

The Regulatory Affairs manager will, in collaboration with Regulatory Affairs colleagues, be responsible for the development and implementation of regulatory activities across varying stages of Vedanta’s programs. This individual will provide operational and tactical guidance to cross-functional program teams, while ensuring compliance with applicable regulatory requirements. The individual will also support effective communication and constructive working relationships with business partners and representatives of regulatory authorities. This is a hands-on role with high visibility and opportunity to advance Vedanta programs.

Here’s What You’ll Do:

  • Provide guidance and share information to cross-functional project teams on regulatory requirements
  • Lead and manage timely submission activities (planning, authoring, editing, reviewing, coordination, submission) including correspondence with regulatory agencies (meeting requests, briefing documents, responses to regulatory authorities, etc.)
  • Participate in agency meetings
  • Participate in the development and optimization of processes and procedures relevant to the submissions including timelines
  • Work collaboratively with internal stakeholders to ensure that regulatory standards and compliance are considered throughout the program lifecycle
  • Continually monitor the regulatory environment to maintain expertise in regulatory principles, landscape changes, competitive products, and implications
  • Perform regulatory intelligence as necessary
  • Engage in continuous improvement initiatives for regulatory affairs processes and/or activities

Requirements:

  • BS/MS in a scientific discipline
  • 5+ years of applicable regulatory experience working in a biotechnology or pharmaceutical organization
  • 2+ years of regulatory experience working in later-phase product development programs
  • Regulatory Affairs Certification (RAC) is a plus
  • Working knowledge of the drug development process is required
  • Good understanding of requirements, context, and content of regulatory submissions
  • Demonstrated ability to understand and interpret regulatory requirements and translate this into concrete  propositions
  • Working knowledge of Agency regulations and industry standards pertaining to regulatory
  • Experience on regulatory submissions for clinical trials and/or marketing authorizations
  • Excellent oral and written communication skills are required
  • Ability to lead and manage projects to completion and experience working in project teams
  • Ability to work in a flexible environment to meet all regulatory requirements and business requirements
  • Strong interpersonal and organizational skills

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

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