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Senior Manager, Regulatory Affairs Vaccines Strategy

応募 後で応募 求人ID R0016592 掲載日 02/05/2020 Location:Cambridge, Massachusetts

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Job Description

OBJECTIVES: 

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

ACCOUNTABILITIES: 

  • Actively participate as member of product Global Regulatory Teams and provide regulatory strategic input for the US.
  • 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.
  • May act 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.
  • Provides US regulatory content and procedural subject matter advice to internal stakeholders regarding assigned regulatory affairs activities. Advises on clinical and nonclinical regulatory strategy of drug development and associated regulations. 
  • In consultation with manager, 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.
  • 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 6 years of pharmaceutical industry experience.  This is inclusive of 4 years of regulatory experience or combination of 6 years regulatory and/or related experience in the vaccine area. 
  • Vaccines and/or biologics experience is strongly preferred.
  • Preferred experience in managing regulatory filings and agency meetings; or managing programs in closely related development area.
  • Relies on 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.
  • Strong skill sets such as oral and written communications, managing and adhering to timelines, negotiation, 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:  collaboration with others, working 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 5 % travel.

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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