Associate Director, Regulatory Affairs Vaccines CMC

Boston, Massachusetts

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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.

Job ID R0144347 Date posted 02/21/2025 Location Boston, Massachusetts

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Job Description

OBJECTIVE / PURPOSE

Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in various stages of development
Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data are identified, obtained and effectively presented for the registration and maintenance of vaccine licenses world-wide
Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that arise during vaccine product development and commercialization
Successfullycommunicates and negotiates with international Health Authoritiesasnecessary, directly and indirectly.

ACCOUNTABILITIES

Leads 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
Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization
Leads regulatory compliance assessments with respect to filing requirements for assigned vaccines and/or changes throughout development and the commercial life cycle
Defines CMC strategy and content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
Supports CMC preparation activities for meetings with Health Authorities on CMC related matters as needed. Interacts directly with international Health Authorities, as required. Participates in and/or leads agency meetings on CMC topics
Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgementand communicating in a professional and timelymanner
Stays up to date withcurrent and evolvingregulatoryCMC requirements, appliesthis knowledge to assigned projects, and shares knowledge and experience with others to support theirdevelopment.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred
6 + years Regulatory CMC experience (vaccines or biologics experience required). Alternatively, 4+ years Regulatory CMC experience combined with 2+ years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance)
Experienced liaison with product development teams; experience on global product developmentprogramspreferred
Sound understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support
Proven ability toprovide strategic regulatory guidance to teams and experience with managing MAA content and format
Demonstrated leadership, problem-solving ability, flexibilityand teamwork
Experience with regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required
Proven capability to apply good judgement in elevating and communicating actual or potential regulatory risks to teams and line management
Excellent written and oral communication skills required.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$149,100.00 - $234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.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. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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.

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Success profile

What makes a successful team member within Vaccines at Takeda?

Integrity
Fairness
Inventive
Perseverance
Honesty
Collaborative

Our leadership

Vaccines represent a new dimension of global impact — successful leadership at Takeda can be encompassed in these four pillars:

Demonstrating strategic enterprise thinking, finding innovative ways to serve patients and build trust, reputation and business

Creating the environment that inspires and enables people to move the organization forward

Focusing on the few priorities and delivers superior results

Elevating the capabilities of the organization for now and the future

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People

Create an exceptional people experience.

Planet

Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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