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Shire CMC Regulatory Affairs Manager in Cambridge, 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 Shire Human Genetic Therapies Inc.for the following job opportunity:
JOB LOCATION: Cambridge, MA
POSITION : CMC Regulatory Affairs Manager
POSITION DESCRIPTION: Shire Human Genetic Therapies Inc. is seeking a CMC Regulatory Affairs Manager with the following duties: Design and execute global Chemistry Manufacturing Control (CMC) regulatory strategies for investigational and marketed products; oversee preparation and filing of CMC sections for regulatory submissions to meet corporate objectives; supervise direct report; represent Shire in interactions with health authorities for CMC issues; provide regulatory guidance to internal groups such as Quality Assurance, Pharmaceutical Sciences and Clinical Operations; collaborate with U.S., Canadian and international regulatory colleagues to guide preparation of regulatory documentation; apply expert knowledge to facilitate global market expansion; coordinate and write CMC sections of IMPDs, INDs, NDAs and MAAs; design and execute strategy for the required data necessary for INDs, IMPDs, CTAs as well as NDA, BLA, MAA and life cycle management of all globally for small molecule and biologic drug products; manage health authority CMC related meetings including developing briefing documentation, written responses and team preparation, and participate in health authority inspections/audits as the Regulatory Affairs CMC representative; develop and execute the content plan for International Core Files (ICFs) to meet legal and regulatory requirements for the countries.
REQUIREMENTS: Bachelor’s degree in Biotechnology, Organic Chemistry, PharmD or related degree plus 3 years related experience. Required skills: coordinate and write CMC sections of IMPDs, INDs, NDAs and MAAs (3 yrs); design and execute strategy for the required data necessary for INDs, IMPDs, CTAs as well as NDA, BLA, MAA and life cycle management of all globally for small molecule and biologic drug products (3 years); manage health authority CMC related meetings including developing briefing documentation, written responses and team preparation, and participate in health authority inspections/audits as the Regulatory Affairs CMC representative (1.5 years); develop and execute the content plan for International Core Files (ICFs) to meet legal and regulatory requirements for the countries (3 years).
Full time. $120,000 - 130,000/year. Competitive compensation and benefits.
Qualified applicants can apply directly to the Shire careers page at: https://jobs.shire.com. Please reference job #R0022050. 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.
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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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Shire 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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.