Manager, Regulatory Affairs CMC
Boston, Massachusetts- Job Level: Senior
- Travel: Minimal (if any)
Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.
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Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions; Submit the compliance submissions such as annual reports (BLA), yearly biologic periodic reports and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up to 20% remote work allowed.
Apply on-line at www.takedajobs.com and search for Req #R0119855.
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:
JOB LOCATION: Cambridge, MA
POSITION: Manager, Global Regulatory Affairs CMC
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Global Regulatory Affairs CMC with the following duties: Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA)to various Global Health Authorities and respond to Health Authority queries in a timely manner; develop the strategies for products in development by working in close coordination with the clinical, non-clinical, global regulatory teams, labelling, etc., to ensure the strategies align across the teams and provide a quality regulatory submission to the Health Authority; ensure the timely submission of any changes that impact the product and receive the regulatory approval to ensure the lifecycle of the product are maintained; ensure the response to the Health Authority queries are provided in a timely and efficient manner by leading with local and international regulatory teams across different regions; interact with the technical operation team and other cross-functional teams and provide regulatory input to build submissions and provide strategic input to authoring teams; support on interactions with the internal teams and external vendors to ensure the required information is received in a timely manner; discussion with R&D teams in the initial phases of the development and as post commercial to ensure any changes are appropriately communicated and strategy vetted by all cross functional teams and interact with analytical teams, stability team, supply chain, packaging and labelling, etc., to ensure the product in development and commercialized products are in compliance during their lifecycle; submit the compliance submissions such as annual reports, yearly biologic product reports, lot distribution reports, license renewals, drug product and structured product labelling (SPL) in a timely manner to ensure the marketed products are in compliance with Health Authority requirements; provide regulatory support during the Health Authority inspections and as well respond to any queries; ensure the Health Authority commitments are tracked by working in close coordination with QA team and any commitments are submitted in a timely manner; provide regulatory assessment for change controls for various markets such as US-FDA, EMA, PMDA, Health Canada, Swiss Medic as well as act as a liaison with in-country regulatory representative to provide the assessments; and prepare the strategy for the appropriate regulatory submission by acting as a liaison with cross functional technical teams and prepare a quality submission. Up to 20% remote work allowed.
REQUIREMENTS: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions; Submit the compliance submissions such as annual reports (BLA), yearly biologic periodic reports and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments.
Full time. 133,200.00 - 223,200.00 USD per year. Competitive compensation and benefits.
Qualified applicants can apply at Takeda careers page at: https://www.takedajobs.com. Please reference job #R0119855. EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.
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, MAU.S. Base Salary Range:
Kristin Test
$133,000.00 - $228,000.00The 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.
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