Regulatory Affairs Manager

4 weeks ago

Waltham, United States HireMinds Full time

Manager, Regulatory Affairs

Waltham, MA


*this job requires 3 days per week on-site in Waltham, MA


Our client is a biopharmaceutical company developing a new generation of oral therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer.


Job Description:


  • Manage document and submission preparation and timelines for regulatory submissions to the FDA, including INDs, DSURs, briefing documents, amendments, etc.
  • Interface with external Regulatory Operations vendor to support submissions to FDA.
  • Manage, track, and file all required SAE reports to FDA in accordance with Agency guidelines.
  • Liaise with CRO in the compilation of documents for ex-US health authority submissions including IMPDs, CTAs, amendments, aggregate safety reporting, and annual updates.
  • Interpret and communicate regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations.
  • Participate in cross-functional sub-teams focused on the execution of regulatory strategy.
  • Contribute to the development of department policies, procedures (RA SOPs), and best practices commensurate with the requirements of a rapidly growing company.
  • Acquire and manage regulatory intelligence, liaise with regulatory intelligence external vendors (as needed), and communicate information to key stakeholders.
  • Assist in the setup, management, and maintenance of the regulatory information management system (RIMS) and support the Quality function with the implementation of a new quality management system (QMS).
  • Previous RIMS experience is a plus.



Qualifications:


  • BS or MS with at least 4 years of direct experience in Regulatory Affairs in the pharmaceutical/biotech industry.
  • Strong knowledge of FDA regulations is required.
  • An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is preferred.
  • Experience in managing the preparation of regulatory documents including individual modules of a new IND, Investigator Brochures, DSURs, IMPDs, CTAs, Orphan Drug applications, briefing packages and other regulatory submissions, in eCTD format.
  • Experience with small molecule drug development is preferred (biologics, cell/gene therapy also acceptable)
  • Experience with early development programs is a plus.
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
  • Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle.
  • A three-day per week onsite presence is required for effective team interaction.

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