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For more information speak to Danielle Boniface on 01707 817313

To apply by email danielle.boniface.02696.10471@justpharma.aplitrak.com

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Senior Specialist, EMEA Regulatory CMC Hertfordshire Ref: BBBH4383

Salary:Up to £0.00 per annum

Added:04 Oct 2018

Region: UK

Category: Regulatory Affairs

Just Pharma are currently searching for a Specialist/ Senior Specialist in Regulatory CMC in Hertfordshire.
As Regulatory Specialists you will be fully involved in the company's strategy to build strong relationships with EU/EEMEA Regulatory Agencies and create regional CMC strategies.


Responsibilities:

* You will be supporting the EU/EEMEA RA CMC Leads who have responsibility to develop CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes.

* Partnering with Global CMC RA Product Leads, the team will ensure right first time submissions, high approval rates, on target launches and positive implementation to maintain patient supplies throughout the lifecycle.

* Certify the regional CMC regulatory strategy is aligned with the global regulatory strategy, Therapeutic Area portfolio, commercial and operational strategies and the Target Product Profile issues impacting product approval, launch or patient supplies will be escalated to CMC Regulatory Affairs Management.

Our client is a TOP Pharmaceutical looking for an experienced CMC specialist to join their expanding team

Please send all CVs to or call 01707 817313

Key Words:

CMC, regulatory, chemical manufacturing control, regulatory affairs, Hertfordshire,UK, United kingdom, microbiology, vaccines

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