Manager, Regulatory Affairs

US-MA-Watertown
7 months ago
Job ID
2017-1066
# of Openings
1
Category
Regulatory Affairs

Overview

The Manager, Regulatory Affairs will be responsible for managing all operational aspects of preparing submissions to regulatory agencies.   Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and plans.

Responsibilities

  • Provide guidance regarding regulatory requirements for global clinical development and registration of pharmaceuticals.
  • Manage the preparation, review and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.
  • Author and/or edit documents to support regulatory submissions.
  • Prepares submission ready final electronic documents utilizing industry-standard authoring, document management and publishing tools to ensure electronic submissions meet all required standards and technical requirements within specified timelines.
  • Support and manage preparation of meeting requests and briefing documents.
  • Ensure compliance with all reporting requirements, including annual and periodic reports.
  • Represent the company in its interactions with the FDA and other regulatory authorities, as appropriate.
  • Manage contract staff and vendors in support of regulatory activities.
  • Maintains submission tracking information and informs project teams and management on real time status of business-critical submissions.
  • Participates in the interpretation and implementation of new health agency guidelines and rules relevant to regulatory submissions.
  • Prepares and maintains SOPs, work instructions and checklists related to templates, electronic document management, electronic submission processes, and archiving.

Qualifications

  • BS or BA in science / technology or an equivalent combination of education and experience preferred
  • A minimum of 5-7 years’ experience in regulatory affairs within the biopharmaceutical industry 
  • Experience and knowledge in content and preparation of INDs, NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical.)
  • Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US, EU and global regulatory environments
  • Working knowledge of GMP, GLP and GCP regulations as well an understanding of the pharmaceutical product life cycle
  • Experienced in managing web-based content and document management experience with records and/or document management standards
  • Excellent regulatory writing skills and a keen attention to detail

Tetraphase Pharmaceuticals is an Equal Opportunity Employer/Females/Minorities/Veterans/Disability

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