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CMC Regulatory Strategy Specialist

Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Start date
Sep 20, 2023

View more

Clinical, Clinical Medicine, Science/R&D, CMC
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details


CMC Regulatory Strategy Specialist


Ipsen Biopharm Ltd

Job Description:


This is a great opportunity to join a dynamic mid-size pharmaceutical company where you will have an opportunity to work with its regulatory teams in US, France, UK and Ireland to name a few locations.  You will be able to expand and broaden your regulatory experience not only with US FDA, but also with multiple countries around the world including, Canada, China, Australia, UK and Brazil.

 The TechOps CMC-Regulatory Strategy Specialist will have responsibility for performing CMC (Chemistry Manufacturing and Control) Regulatory activities, to include geographical expansion, of Ipsen’s commercially approved products as assigned by the Sr. Dir./Director TechOps CMC-Regulatory Strategy.

Job Responsibilities

  • Implement the TechOps CMC-Regulatory strategy as defined by the Sr. Dir/Director TechOps CMC-Reg Strategy and create a proposed implementation plan for regulatory submissions and obtain agreement from all relevant stakeholders.

  • Compile regulatory technical documentation including updating CTD sections with process and analytical data extracting information from reports, batch records, analytical procedures and quality events as appropriate.

  • Liaise with SMEs and participate in the authoring of Regulatory Response to Questions while thinking critically.

  • Ensure questions from Regulatory Authorities for our global markets are responded to efficiently and on-time in order to meet expected submission approval timelines.

  • Support the review of Change Controls for assigned products and the identification of any Regulatory impact and CMC-Regulatory requirement.​

Knowledge, Abilities and Experience

  • Degree/Masters in Pharmaceutical /Biological/Chemical Science or relevant scientific discipline.

  •  At least 5 years of work experience in multinational Life Science companies with 2 years relevant experience in the preparation of Module 2.3 and 3 Regulatory documentation for small molecules and/or biologicals is essential.

  • Experience should include registration and post-approval activities in US, EU and major Intercontinental markets e.g. China, Japan and ideally update of Medical Device Technical files.

  • Demonstrated experience in the implementation of CMC-Regulatory strategies for major regulatory submissions.

  • Understanding of Quality activities and assessment of cGMP compliance, site registration and licensing.

  • Fluent in French is a plus.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.


Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit or


Company info
1 Main Street
Unit 700
United States

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