Associate Director, Regulatory Affairs Vaccines CMC

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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

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.

Salary : $149,100 - $234,300