Regulatory Affairs Manager
Company: Kerry Search Partners Agency
- Location: Dublin, Ireland
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Manager, Regulatory Affairs
I’m working with a global pharmaceutical company to hire a Manager, Regulatory, focused on injectable products. It’s a permanent role based in Ireland.
The role
- Develop and drive global CMC regulatory strategy for a portfolio of injectable products
- Author and review post-approval CMC submissions, variations and supplements
- Support manufacturing sites with regulatory strategy and change control
- Lead responses to health authority queries and take part in agency meetings and inspections
- Act as the regulatory subject matter expert on cross-functional project teams and mentor colleagues
What you’ll bring
- A science degree and a background in pharmaceutical Regulatory Affairs
- Hands-on CMC experience with injectable, parenteral or combination products
- Strong knowledge of global requirements, especially US/FDA, as well as CFR, USP, Ph. Eur. and cGMP
- Clear writing and good project management skills
- People management experience, and TOPRA or RAC, would be a plus
On offer: competitive salary, bonus, health insurance, pension and real career progression in a global organisation.
If this sounds like you, or someone in your network, drop me a message for a confidential chat.
#RegulatoryAffairs #CMC #Injectables #PharmaJobs #IrelandJobs
