Senior Director, GRA Pharmaceuticals - Philadelphia, PA, United States - Takeda

Description

Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.

In an environment that fosters lifelong learning and a growth mindset, you'll have the support you need to thrive — at work and beyond.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.

You will also influence changing regulations and guidance documents; interface with outside regulatory agencies and trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy.

As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals.

Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages

Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.

Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.

Serve as a member of the GRA-CMC Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.

Provides leadership of GRA CMC Pharmaceuticals – in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.

In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.

Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.

Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.

Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet.

Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.

Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.

You will also influence changing regulations and guidance documents; interface with outside regulatory agencies and trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy.

As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals.

Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages

Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.

Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.

Serve as a member of the GRA-CMC Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.

Provides leadership of GRA CMC Pharmaceuticals – in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.

In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.

Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.

Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.

Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet.

Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.

Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e

g Languages:
Fluent in English, additional languages desirable

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
#The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
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based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Full time When you join our Regulatory Affairs team, you'll help ensure the fastest, safest path for our treatments to get to patients.

We continue building on our 240-year history as a global biopharmaceutical leader through our innovative mindset and lean governance.

Find everything you need on our Regulatory Affairs team to positively impact patients' lives while taking strides within your own.

Oversee regulatory activities
Ensure regulatory compliance
Nahid Latif - Head, Global Regulatory Affairs
Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Group and Labeling
Nahid Latif - Head, Global Regulatory Affairs
Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Group and Labeling
Nahid Latif - Head, Global Regulatory Affairs

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas.

Check out our pipeline and see how we'll continue delivering a steady stream of next-generation therapies.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Inclusion
Inclusion
Innovation

Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work. Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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