Posted to MedZilla on 4/21/2018


Takeda Pharmaceuticals

US-MA, Associate Director, Global Regulatory Affairs Regulatory Intelligence R0001204-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, GRA Regulatory Intelligence in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Director, GRA Regulatory Intelligence working on the Global Regulatory Affairs team, you will be empowered to be strategic and collaborative, and a typical day will include:

POSITION OBJECTIVES:

  • Global regulatory intelligence contact for key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, Japanese and EM Reg Intel colleagues.
  • Support regulatory interactions on policy and advocacy issues externally, including building relationships with key regulatory decision makers and industry networks globally. As the secretariat of the Global Regulatory Intelligence & Policy (GRIP) Network, coordinates the creation of a vision for the Network to work collaboratively with regional colleagues to deliver a work plan to meet that vision.
  • Coordinates GRIP colleagues, to define and oversee the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on Takeda s products and goals. As such bring functional excellence to Regulatory Policy and Intelligence. Develop best practices and excellence in execution within the department and cross-functionally.
  • Develop the strategic assessments of external regulatory changes globally and, work with subject matter experts within the Company, to support the decision making process to understand and prioritise the regulatory risks & opportunities globally: , develop strategies/ positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.

POSITION ACCOUNTABILITIES:

  • Represent GRIP and GRA on internal and external forums / networks as assigned. Provides impactful summaries and strategic advice, back to the business, regarding assigned internal / external activities. Positively influence the regulatory environment as needed, to meet business needs.
  • Work with GRIP colleagues to oversee GRA participation in regional committees to drive effective networking and representation to ensure a one voice policy
  • Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may bear influence to Takeda and propose action plan.
  • Play a key role in development and implementation of appropriate systems, processes and standards within GRIP and GRA and across Takeda as assigned.
  • Work closely and partner with a number of Subject Matter Experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. This includes to liaise closely with colleagues (R&D, Policy, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on Takeda position.
  • Provide leadership for specific external engagement and / or Regulatory Policy activities, as assigned. In collaboration with Subject Matter Experts and/or Therapy Area Regulatory leads develop focused analytical responses to therapy area and regional procedural queries.
  • Contribute to the management and maintenance of special projects such as Global Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned.
  • Work with external parties/consultants as appropriate to define messaging approach and strategy.
  • Ensures regular RI updates to provide education, knowledge sharing, newsletters, reports and other modes of communication to advance regulatory expertise and decision making for the region
  • Maintain consistent oversight of deliverables. Keep all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
  • Lead routine and ad hoc meetings within function and cross-functionally. Presents to senior management as relevant.

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
  • A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years regulatory experience or a combination of 8 years of regulatory and/or related experience in both development and post-marketing phases.
  • Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US), with a good understanding of basic regulatory requirements in the EU and emerging markets. Good knowledge of intelligence tools and methods
  • Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Proven track record working with the US FDA, specific experience in government affairs or policy is also desired
  • Excellent skills in collaboration/relationship building. And generallystrong in all skills such as influencing, negotiation,. written and oral communication skills as well as managing and adhering to timelines, integrity and adaptability. Proven ability at stakeholder engagement across organizational levels and boundaries
  • Must have a good working knowledge 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.
  • Ability to develop regulatory strategy to balance short and long term objectives, and drive teams to make decisions and achieve deliverables within agreed parameters and timescales
  • Generally strong in working well with others, within global teams and communicating with senior leadership.
  • Experience managing relationships with CROs and/or contractors also preferred.

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.

TRAVEL REQUIREMENTS:

  • 20%, some international required.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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