Team Lead, Global Reg Affairs, Device, PDT
Lexington, Massachusetts- Job Level: Senior
- Travel: Minimal (if any)
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
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Job Description
Shire Human Genetic Therapies, Inc., a Takeda company, is seeking a Team Lead, Global Reg Affairs, Device, PDT in Lexington, MA with the following requirements: Master’s degree in Regulatory Affairs or related field or foreign academic equivalent plus 5 years of experience. Prior experience must include: Lead a team of engineers and specialists through device combination product projects creating compliant design history files towards regulator dossiers for agency submission (5 yrs); coordinate and guide a team of regulatory labelling specialists to produce instruction for use documents for the safe use of drug delivery devices (3 yrs); negotiate with global regulatory agencies and persuade the agencies to accept data packages towards drug device approval (5 yrs); monitor and assess regulatory guidelines and standards for the successful and compliant development of device drug combination product modalities (3 yrs). 15% travel required.
Apply on-line at www.takedajobs.com and search for Req # R0076679
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:
Lexington, MAU.S. Base Salary Range:
29,400.00 - 46,200.00The 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
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeDuring my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.
Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations
When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.
Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office
Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.
Alison Handley, Head, Center for External Innovation
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Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
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.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
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.
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