Posted to MedZilla on 8/13/2018


Takeda Pharmaceuticals

US-MA, Associate Director Regulatory Affairs Vaccines Strategy R0001422-MZ


 
 

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Job Description

OBJECTIVES:

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

ACCOUNTABILITIES:

  • 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.
  • Acts as primary regulatory authority contact for projects of responsibility.
  • 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 Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
  • Acts 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 non-clinical and clinical aspects of drug development and associated regulations.
  • Accountable for overall content and management of local regulatory components and filings i.e. NDA/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.
  • Leads and manages health authority meetings as applicable for specified projects.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • BS degree, advanced scientific degree preferred.
  • A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience in the vaccine area.
  • Vaccines and/or biologics experience is strongly preferred.
  • Preferred experience in managing filings resulting in first-time approval; or managing 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.
  • Must be strong overall in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership.

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling and reaching for objects.
  • Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
  • Requires approximately 20 % travel.

Empowering Our People to Shine

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