CMC Regulatory Strategy Specialist
Ipsen Biopharm Ltd
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.
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.