Shire Manager, Regulatory Strategy CMC in Lexington, Massachusetts

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Takeda Human Genetic Therapies Inc. for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Manager, Regulatory Strategy CMC

POSITION DESCRIPTION: Takeda Human Genetic Therapies Inc. is seeking a Manager, Regulatory Strategy CMC with the following duties: manage Regulatory Affairs activities for developing global chemical, manufacturing and controls (CMC) strategies for Takeda’s global portfolio of early development programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, post-approval changes or compliance updates; provide collaborative support for execution of global CMC strategies; provide regulatory support, guidance and expertise to internal groups such as Product Development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into the development programs by engaging in early and late stage development, analytical development, product stability, product packaging and labeling requirements; track global submission activities including Biologics and Chemically Synthesized Products; provide expertise in pharmaceutical development of global productions and eCTD requirements; manage review and approval of regulatory submissions for IND, NDA; apply electronic software for submission and life cycle management of regulatory submissions; engage in early and late stage development, analytical development, product stability, product packaging and labeling requirements; utilize knowledge of regulatory requirements of the Health Authorities such as FDA, EMA, & ROW markets.

REQUIREMENTS: Bachelor’s degree in Chemistry, Pharmacy, or related field plus 5 years related experience. Will accept any level of experience in the following required skills: manage review and approval of regulatory submissions for IND, NDA; apply electronic software for submission and life cycle management of regulatory submissions; engage in early and late stage development, analytical development, product stability, product packaging and labeling requirements; utilize knowledge of regulatory requirements of the Health Authorities such as FDA, EMA, & ROW markets.

Full time. $157,000.00 - $165,000.00/year. Competitive compensation and benefits.

Qualified applicants can apply directly to the Takeda careers page at: https://jobs.Takeda.com. Please reference job #R0030484. 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, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.