Posted to MedZilla HealthCare on 8/19/2018


Takeda Pharmaceuticals

US-MA, Director, Global Regulatory Affairs Development - Neuroscience R0002616-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 aDirector, GRA Development - CNS in ourCambridge MAoffice.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director, GRA Development - CNS working on theGlobal Regulatory Affairs team, you will be empowered tobe strategic andinnovative, and a typical day will include:

OBJECTIVES:

  • Provides global regulatory oversight for multiple projects covering a minimum of one highly active therapy area, focused on nonclinical and clinical aspects of drug development and associated regulations.
  • As Global Regulatory Leader (GRL) for one or more team, collaborates with all Takeda regional counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility.
  • Oversee regulatory intractions with health authorities (eg, FDA) and provide interpretation of feedback to the team and business
  • May have staff, if so, provides leadership and training for multiple direct reports including those that serve as regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.

ACCOUNTABILITIES:

  • Oversees one or more Global Regulatory Teams (GRTs) with global oversight and responsible for ensuring global regulatory strategies are written and executed according to plan.
  • Oversees and accountable for all relevant submissions and approvals within therapeutic area of responsibility for assigned programs.
  • Oversees and accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local Takeda affiliates within therapeutic area of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
  • May supervise direct reports. If asked to mange as staff, manages, trains and provides oversight for staff day-to-day activities.
  • Leads and manages meetings with regulatory authorities and agency meetings; or delegates and oversees direct reports; negotiates on behalf of project team as necessary.
  • Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
  • Lead regulatory reviewer in due diligence for licensing opportunities.
  • Manages personnel within group to ensure coverage for project and therapy area(s) responsibilities; Elevates needs when necessary
  • Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
  • Presents to senior management.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience; advanced degree preferred
  • A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience.
  • Preferred experience in managing NDAs/MAAs; global involvement preferred.
  • Experience leading teams required.
  • Solid working knowledge of drug development process and regulatory requirements; knowledge of US and EU regulatory environment; Canada, Emerging Markets, post-marketing experience a plus.
  • Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates 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 and able to train/present/convery new knowledge related to 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.
  • 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.

TRAVEL REQUIREMENTS:

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

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 attakedajobs.com.

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