SENIOR ASSOCIATE – SPECIALIST, GLOBAL REGULATORY AFFAIRS CMC

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Job Description About the role.
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.
Senior Associate – Specialist, Global Regulatory Affairs CMC role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows.
With supervision, support the execution of regulatory CMC investigational, registration and post- approval strategies for assigned products.
Support RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
With supervision, prepare   project plans and timelines for CMC submission activities and responsible for organization of CMC- related documents for regulatory submissions.
Expected to have a sound understanding of global RA CMC regulations and guidelines and participate in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance.
Has ability to apply this understanding to support the development and execution of strategies to enhance probability of regulatory success and regulatory compliance.
Sound analytical or process understanding that enables the development of robust and accurate submissions.
Assist in the coordination of communication and collaboration among internal and external colleagues.
Minimum Requirements/Qualifications.
PhD / PharmD, or MS/BS with 3+ years of relevant pharmaceutical experience (Reg ulatory CMC, Pharmaceutical Development, Analytical Development, GMP Manufacturing, Quality Assurance, etc.)   Understanding of scientific principles relevant to global drug development and post-market support.
Ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
Analyze issues with attention to detail.
Ability to assess alternative approaches.
Base regulatory strategy recommendations on precedents and other regulatory    intelligence as well as regulations and guidelines.
Exercises good judgement in elevating and communicating actual or potential issues to line management.
Understands who is responsible for different decisions and escalates as necessary      Support to apply decisions taken by the company   Demonstrates sound understanding and knowledge of the principles, practices and processes within the GRA organization and with key stakeholder groups.
Consistently demonstrates a “can do” attitude which results in others willingness to work together to drive results.
Demonstrates awareness of company's mission, culture, functions, policies and procedures to operate effectively     Proactively establishes relationships to accomplish individual objectives     Demonstrates attention to detail and problem -solving abilities     Good judgement in elevating and communicating actual or potential issues to line management.
Excellent written and oral communication skills.
More about us.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
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" following Takeda's Hybrid and Remote Work policy.
#LI-Hybrid #LI-AA1 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.
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Base Salary Range.
$ 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.
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based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s.
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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.
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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.