USA - Associate Director-Regulatory Strategy at Biotech/Pharma Cambridge, MA
Contract: one year
Location: Cambridge, MA
Regulatory Strategy Objectives::
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 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.
Working hours: 8 AM - 5 PM
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 Takeda.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
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..
Relies on extensive experience and judgment to plan and accomplish goals.
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