Associate Director, Regulatory Affairs Vaccines Strategy

Location
Cambridge, MA
Posted
Feb 20, 2019
Ref
R0001422
Required Education
Bachelors Degree
Position Type
Full time

Overview

Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Our US Offices are in Cambridge, MA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.

While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

Responsibilities

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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

Learn more at takedajobs.com.

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