Regulatory Affairs Specialist

Regulatory Affairs Specialist

Natick, MA • Full Time

Job Duties

  • Monitor the activities of the company lab, the chemistry manufacturing control (CMC) company to ensure that the U.S. and international registration needs are met, risks are minimized, and domestic and international product-submittal processes are streamlined;
  • Communicate with regulatory agencies domestically and internationally regarding pre-submission strategies, potential regulatory pathways, and compliance test requirements, and clarification and inquiry of submissions under review;
  • Generate and review protocols and filing documents to ensure compliance with administrative policies and procedures, administrative completeness, and key regulatory requirements;
  • Develop and maintain regulatory files, records, and reporting systems; and
  • Research the existing and emerging regulations, standards, or guidance documents in the global biotechnology and pharmaceutical industries and interpret the regulations and rule changes to the company.

Requirements

  • Bachelor’s degree in Public Health, Regulatory Affairs, or a related discipline; advanced degree preferred
  • A minimum of one (1) year of experience in the area of regulatory affairs in the biotechnology and pharmaceutical industries
  • Working Knowledge of FDA and international regulatory requirements and procedures
  • Knowledge of statistics, especially biostatistics
  • Excellent writing skills with ability to write detailed information for submissions
  • Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
  • Strong verbal skills including presentation skills
  • Strong interpersonal skills including the ability to interact with all levels of the company
  • Strong computer skills, including Microsoft Office
  • Excellent ability to manage several parallel deliverables
  • A self-starter with the ability to work independently with minimal supervision and as part of a small team
  • Detail-oriented, well organized, and driven to meet deadlines and program goals
  • Awareness of current trends in Regulatory Affairs

To apply, please submit your cover letter/ resume to: info@hebecell.com