Cco - Boston, MA, United States - Takeda

Description

Director, Regulatory Affairs Vaccines CMC
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan.

Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus.

Takeda's team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs.

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 Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.

You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc.) to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.

The role requires strong focus on analytical, manufacturing, and facilities compliance.

You will also demonstrate leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization.

You will successfully communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed
Participate in technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization
Lead regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle
Define CMC content (data and documentation) requirements for regulatory submissions and compile/review this content for conformance with established requirements
Interact directly with international Health Authorities, as required. Ensure project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share knowledge and experience with others to support their development
May serve as direct/matrix manager of RAV CMC staff, depending on project. Responsible for prioritization of workload and professional development of staff where applicable.
BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred.
At least 10 years Regulatory CMC experience (vaccines or biologics experience required). Alternatively 5 years Regulatory CMC experience combined with 5 years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance). Experience with managing BLA/MAA content and format required.
Experience with regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required.
Understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support. Proven ability to provide strategic regulatory guidance to teams.

Demonstrated ability to deal with issues of critical importance, provide regulatory advice and experience with developing reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.

Exercises good judgement in elevating and communicating actual or potential regulatory risks to teams and line management.
Some international travel may be required.
401(k) with company match and Annual Retirement Contribution Plan
~ Tuition reimbursement Company match of charitable contributions
~ Community Outreach Programs

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 Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.

You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc.) to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.

The role requires strong focus on analytical, manufacturing, and facilities compliance.

You will also demonstrate leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization.

You will successfully communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed
Participate in technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization
Lead regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle
Define CMC content (data and documentation) requirements for regulatory submissions and compile/review this content for conformance with established requirements
Interact directly with international Health Authorities, as required. Ensure project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share knowledge and experience with others to support their development
May serve as direct/matrix manager of RAV CMC staff, depending on project. Responsible for prioritization of workload and professional development of staff where applicable.
BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred.
At least 10 years Regulatory CMC experience (vaccines or biologics experience required). Alternatively 5 years Regulatory CMC experience combined with 5 years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance). Experience with managing BLA/MAA content and format required.
Experience with regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required.
Understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support. Proven ability to provide strategic regulatory guidance to teams.

Demonstrated ability to deal with issues of critical importance, provide regulatory advice and experience with developing reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.

Exercises good judgement in elevating and communicating actual or potential regulatory risks to teams and line management.
Some international travel may be required.
401(k) with company match and Annual Retirement Contribution Plan
~ Tuition reimbursement Company match of charitable contributions
~ Community Outreach Programs

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 What makes a successful team member within Vaccines at Takeda?
Demonstrating strategic enterprise thinking, finding innovative ways to serve patients and build trust, reputation and business
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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