Takeda

Director, Global Regulatory Affairs, Neuroscience

Takeda • $177K — $278K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • BSc is preferred (BA accepted).
  • 10+ years of pharmaceutical experience, including 6 years of regulatory or a mix of regulatory and related experience.
  • Experience in reviewing, authoring, or managing regulatory submissions is preferred.
  • In-depth knowledge of drug development and regulatory requirements, including FDA and international regulations.
  • Ability to interpret complex scientific data related to regulatory strategies.

Responsibilities

  • Define and lead global regulatory strategies for complex projects.
  • Provide strategic guidance for regulatory teams and ensure compliance across projects.
  • Anticipate regulatory risks and develop proactive solutions.
  • Oversee US FDA submissions and manage FDA interactions effectively.
  • Coordinate global regulatory submissions in alignment with local regulations.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan with company matching contributions.
  • Tuition reimbursement program for continued education.
  • Paid volunteer time off and community service opportunities.
  • Generous vacation and sick leave policies.
Full Job Description
Job Description

About the role:

The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams.

  • Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.


  • Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations.


  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.


  • Participates in cross-functional initiatives within Global Regulatory Affairs and Takeda R&D.


How you will contribute:

  • The Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.


  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.


  • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.


  • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs.


  • Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.


  • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.


  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.


  • Participates with influence in departmental and cross-functional task-forces and initiatives.


  • Lead regulatory reviewer in due diligence for licensing opportunities.


  • Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.


  • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.


  • Responsible for demonstrating Takeda leadership behaviors


Minimum Requirements/Qualifications:

  • BSc Degree, preferred. BA accepted.


  • 10+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience.


  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.


  • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.


  • Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.


  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.


  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.


  • Demonstrates acceptable skills with increasing independence 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.


  • Must work well with others and within global teams.


  • Acceptable and independent skills 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.


Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

About Takeda

Takeda Pharmaceutical Company Limited is a global pharmaceutical company that develops and markets pharmaceutical products. The company's products are used to treat a wide range of medical conditions, including cardiovascular and metabolic diseases, respiratory diseases, and cancer. Takeda Pharmaceutical Company Limited was founded in 1781 and is headquartered in Tokyo, Japan. The company has operations in more than 80 countries and employs more than 49,000 people worldwide.
Learn more about Takeda
Size
47,347 employees
Market Cap
$48.2 billion
Industry
Pharmaceuticals & Biotech
Founded
1781
5 Year Trend
+15.6%
NASDAQ
TAK
* Ladders Estimates

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