Posted to MedZilla on 3/26/2017


Takeda Pharmaceuticals

US-MA, Director, Global Regulatory Intelligence 1602686-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. 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, central nervous system 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.
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!

OBJECTIVES:

  • Global regulatory intelligence contact for key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, US and EM Reg Intel colleagues.
  • Support regulatory interactions on policy and advocacy issues, including building relationships with key regulatory decision makers globally. Provide guidance for company relationships with other regulators and decision makers to further expand these relationships.
  • Leads Global Regulatory Intelligence (GRI) to create vision for Regulatory Intelligence working collaboratively with regional colleagues with delivery of a work plan to meet that vision. Also works closely with the Regional Policy leads to drive success at the regional regulatory interface.
  • With GRI & Policy colleagues, 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. Drive best practices and excellence in execution within the department and cross-functionally.
  • Utilizes his / her experience to oversee the strategic assessment of external regulatory changes globally and, to work with subject matter experts within the Company, to drive or support the decision making process to understand and prioritize the regulatory risks & opportunities globally: the internal impact analyses, development of strategies/ positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.

ACCOUNTABILITIES:

  • Represent Global Regulatory Policy & Intelligence 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.
  • 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 Regulatory Policy & Intelligence within 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 or has primary responsibility for 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.
  • Manages personnel within group to ensure coverage for regional responsibilities; Elevates needs when necessary.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
  • Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.
  • Deep understanding of regulations and guidances governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Sound 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 a major regulatory agency, specific experience in government affairs or policy is also desired
  • Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries
  • Must be strong overall and able to train/develop staff 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.
  • Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
  • Experience in managing personnel required; 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.


we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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