Job Description

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Objectives:

• As a key member of the Global Regulatory Affairs Regional leadership team, this role is involved in establishing the strategic direction and implementation of regulatory strategies for the company’s products within their Growth and Emerging Markets (GEM).

• Is a standing member of the Growth and Emerging Markets Business Unit (GEM BU) extended leadership team representing global and local regulatory affairs personnel for the region to ensure regulatory activities are aligned with the commercial priorities for the GEM BU

• Acts as the lead Regulatory Affairs expert within the Company for the Growth and Emerging Markets. As such, he/she will provide the leadership and initiative for regulatory Activities, working closely with internal functional experts within the Research & Development, Commercial and Manufacturing organizations.

• Develops strategic regulatory approaches in conjunction with the Global RA Strategy that supports the full development strategy and provides regulatory direction and oversight into development plans to achieve the company’s strategic objectives.

Primary Responsibilities:

• Provides regulatory expertise and ensures appropriate regulatory guidance and support are provided to development teams and established products teams across countries within GEM.

• Provides leadership and drives functional aspects of the global regulatory process to ensure timely filing and approval of new products and maintenance of existing products in territories of responsibility in accordance with business

• Collaborates with senior management to provide planning, development and implementation of appropriate regulatory strategies to ensure ongoing compliance with regulatory requirements within GEM

• Directly manages the GEM RA team which is a team of regulatory professionals based in USA and Singapore that provide day to day regulatory support and expertise between the Global Program Teams and the Local Operating Company regulatory affairs personnel

• Chairs RA Leader group with GEM RA team and the RA Area Heads within GEM Business Unit

• Responsible for regulatory input to all global regulatory development plans/strategies for all areas within GEM.

• Has strong understanding of the commercial dynamics of GEM as it relates and impacts regulatory strategies and issues for the region. Has experience in working closely with GEM BU commercial personnel

• Serves as primary regulatory liaison for all territories of responsibility to other entities of the company (Plasma Derived Therapies, Vaccines and Marketed Products) ensuring global consistency for the key development initiatives.

• Provides insight and continual research into the future direction of Regulatory Affairs and how to best prepare for emerging trends, regulations and changes, enabling the company to take a proactive approach and proactive planning to future business requirements.

• Maintains oversight of regulatory intelligence for territories of responsibility

• Provides RA guidance and support for individual territory regional development activities.

• Represents GRA in strategic planning with GEM BU leadership

• Oversees in-license RA activities identified by the GEM BU

Requirement / Criteria:

• Bachelor’s degree required, scientific or technical focus preferred.

• Master’s or other advanced degree (MD, PhD, PharmD) preferred.

• 16 years’ experience in the pharmaceutical industry

• 12 years’ experience in Regulatory Affairs

• 10 years of progressive management experience

• Proven track record in managing complex organizational compliance issues.

• Proven track record in identifying and implementing organization-wide regulatory/compliance initiatives

• Demonstration of successful submissions/management for territories outside US, Europe and Japan, as well as fundamental knowledge of regulatory processes within US, Europe and Japan. Outstanding interpersonal, communication, and organizational skills are required as this position works cross-functionally with development functions / staff from Clinical R&D and Quality Assurance as well as externally with manufacturing and preclinical.

• Proven track record in managing global, cross-functional projects or organizations

• Specific experience in rarely occurring, highly visible/highly important regulatory interactions such as participating in/preparing the project team for key global Health Authorities meetings

• Previous experience serving on industry external committees (DIA, PhRMA) is a plus.

• Thorough knowledge of the drug development process, with focus on IND and NDA processes. Experience with biologics and small molecule products and working with international regulatory agencies.

• Demonstrated ability to interface with relevant regulatory authorities.

• Excellent regulatory judgment and knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.

• Results driven and team-oriented with the ability to influence outcomes.

• Must be able to innovate, analyze and solve problems with minimal supervision and have exceptional attention to detail.

• Excellent project and time management skills needed to drive multiple complex projects simultaneously.

• Demonstrated ability to lead and motivate a global staff. Ability to work collaboratively as a partner, at all levels, while maintaining successful relationships.

• Ability to function at a very high level of independence within a highly matrixed environment.

• Excellent leadership and management skills. Excellent written and oral communication skills.

• Has a mature and calm demeanor, which is maintained when under pressure

• Solution orientated

• Supportive of colleagues to achieve shared objectives by encouraging collaboration, candor and open sharing of information and expertise

• Approximately 40% domestic and international travel is required.

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