• location: Cambridge, MA
  • type: Contract
  • salary: $165 - $171.65 per hour

job description


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Job Title: Associate Director-Regulatory Strategy IV

Position Description

  • Responsible for regulatory activities supporting the development of vaccine candidates
  • Manages regulatory projects and submissions for vaccine candidates
  • Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
  • Provides regulatory oversight for assigned projects, focused on non-clinical and clinical, and CMC aspects of drug development and associated regulations.
  • Leads and directs the work of others as part of a matrixed organization
  • Collaborates with all Company regulatory counterparts to ensure a global regulatory alignment for all projects within area of responsibility
  • Provides global CMC regulatory program support to vaccine programs in various stages of development.
Position Responsibilities

  • Co-ordinates and is accountable for all Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time.
  • Coordinates interactions with and submissions to FDA. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact.
  • Ensures compliance with both internal Company process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
  • Act as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US and Canada. Provides a regulatory strategic focus on all aspects of drug development and associated regulations.
  • Accountable for overall content and management of local regulatory components and filings i.e. BLAs, INDs . Contribute to overall strategy and content for local label development.
  • Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
  • Actively participate as member of Global Regulatory Teams supporting products.
  • Responsible for US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.
  • Manages health authority meeting preparation as applicable for specified projects.
  • Prepares and manages regulatory submissions for assigned vaccines in various phases of development.
  • Supports regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development.
  • Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
  • Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Evaluates change controls for regulatory impact and filing requirements.
  • Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Company.
Position Requirements

  • BS, advanced scientific degree preferred.
  • A minimum of 7years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 10 years regulatory and/or related experience in the vaccine area.
  • Vaccines and/or biologics experience is preferred..
  • Preferred experience in managing multiple filings resulting in first-time approval; or managing multiple programs in closely related development area.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy.
  • Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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