Associate Director, Regulatory Affairs

Location
Cambridge, MA
Posted
Nov 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Associate Director (AD), Regulatory Affairs (RA) will report to the Vice President, Regulatory Affairs and will work with cross-functional teams to develop worldwide regulatory strategies and execute submission activities to US, EU and international Health Authorities for Syros Pharmaceuticals’ gene control therapeutics. The successful applicant will serve as a Regulatory Program Lead for one or more programs in the clinical pipeline as well as work across all programs to support the development and commercialization of Syros products globally. Additional responsibilities include involvement in the writing of regulatory submission documents, coordinating all aspects of paper and electronic regulatory submissions, and proactively monitoring the global regulatory landscape to provide relevant regulatory intelligence to the development teams.

The successful candidate will:

  • Work with RA leadership to develop innovative US and global regulatory strategies and to lead the planning, preparation (including authoring where relevant) and execution of regulatory submissions throughout the product life cycle. This will include Requests and Briefing Documents for Health Authority meetings, Clinical Trial Applications (CTAs, INDs), Pediatric Plans, Orphan Designations, Expedited Pathway Applications (Breakthrough, PRIME), and Marketing Applications (NDAs, MAAs)
  • Develop detailed regulatory project plans and support regulatory activities relating to a specific product and/or project
  • Serve as the core team representative and participate on one or more programs in the Syros pipeline
  • Provide regulatory guidance and education through interpretation of regulations, policies and guidelines
  • Create and update regulatory strategy documents, and regulatory components of target product profiles documents
  • Coordinate timely, high quality responses to Health Authority questions
  • Serve as a liaison within internal departments at Syros, with CROs, and with regulatory personnel at the various Health Authorities
  • Maintain regulatory files in a format consistent with internal requirements
  • Provide technical regulatory review and expertise for the creation and maintenance of internal SOPs, policies and guidance documents to ensure regulatory compliance

Job Requirements

  • Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years of experience working in the biotech or pharmaceutical industry
  • Excellent written and verbal communication skills, including negotiation skills
  • Solid understanding of, and ability to interpret, global regulations, policies and guidelines (FDA, EMA, PMDA, etc.)
  • Ability to think strategically and to proactively identify issues in various aspects of the drug development process
  • Experience with development of regulatory strategy documents, and contributing to clinical development plans
  • Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.
  • Knowledge of biomarkers, CTAs, companion diagnostics, and familiarity with IDE, PMD and IVD requirements is a plus
  • Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects
  • Ability to work in a team environment, possessing excellent interpersonal and communication skills to work effectively with other team members and departments at various levels and with CROs and external consultants
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting
  • RAC certification and/or advanced degree are preferred

Finally, the candidate will need to embrace our values:

As a team we:

  • are committed to transform the lives of patients
  • are pioneering in our science
  • challenge each other to achieve excellence
  • work with passion, integrity and respect
  • like rigorous work and serious fun