Posted to MedZilla on 4/25/2017


Takeda Pharmaceuticals

US-MA, Senior Director, Global Regulatory Affairs Development CNS 1602930-MZ


 
 

OBJECTIVES:

  • Defines, develops and leads global/regional strategies to maximize regulatory success towards achievement of program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with regulatory requirements.
  • Provides regulatory expertise for multiple projects within core therapeutic area, focused on non-clinical and clinical aspects of drug development, post marketing compliance and life cycle management.
  • Provides leadership and development for multiple direct reports, potentially in various regions/sites, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
  • Provides direction to senior leadership and teams on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas of responsibility enabling proactive approach and planning to future business requirements
  • Acts as deputy to the therapeutic area regulatory head, attending critical internal leadership team meetings, as appropriate. Provides regulatory guidance and participates in critical regulatory meetings with regulatory authorities. Determines Takeda impact and remediation requirements and provides interpretation and direction to the business

ACCOUNTABILITIES:

  • Oversees global regulatory leads and staff responsible for ensuring regulatory strategies are written, reviewed and executed according to plan. Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with regulatory requirements
  • Collaborates with Takeda counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility. Identifies regulatory requirements and trends across therapeutic area of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
  • Directs and oversees multiple projects, generally has global/regional oversight for compounds in a minimum of one disease area.
  • Oversees and accountable for working with other RA functions to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility as outlined in the global regulatory strategy.
  • Works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables as defined within the global regulatory strategy and plan. Approves global regulatory strategies and authors for more complex regulatory strategies as needed; over see execution, generally delegates to staff.
  • Supervises multiple direct reports. Manages, trains and provides oversight for staff day-to-day activities.
  • Leads critical interactions/meetings with senior representatives of appropriate health authorities; delegates to staff, as appropriate, for other health authority interactions 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.
  • Presents to senior management.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
  • A minimum of 15 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 15 years regulatory and/or related experience.
  • Thorough knowledge of regulations and guidances governing drugs and biologics in all phases of development in the US and EU, with a good understanding of basic regulatory requirements in emerging markets
  • Solid understanding and ability to interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
  • Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; global involvement also preferred. Must be able to provide guidance in interpreting regulatory regulations and guidelines. Strong leadership, communication (written and verbal), and management skills are required.
  • Demonstrated skills in complex reasoning and risk management assessments
  • Excellent written, communication, project management and presentation skills (articulate and persuasive). Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
  • Analytical, strategic thinker with proven leadership ability that demonstrates professionalism and establishes respect with excellent people management skills. Demonstrated ability to develop others in the area of regulatory strategy, including as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offering creative solutions and strategies, including risk mitigation strategies.
  • Ability to influence others, at all levels of the organization, without direct hierarical authority, and affect change across organizational boundaries. Ability to collaborate effectivey with peers, within global teams and in 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.

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 or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 30% travel.



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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.