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Job Details

Regulatory Affairs Director

Company: Hobson Prior
Location: Berkshire
Reference: LH00612
Closing Date: 23 Jan 17
Type: Permanent
Salary (£): On Application
Benefits: From £90,000

Job Summary:

EU Regulatory Affairs Director

Requirements:

EU Regulatory Affairs Director

Company Profile

- East coast based US Biotech working at their EU HQ in Berkshire

- Developing first of its kind product

- Rapid expansion forecasted over the next 2 years

 

Job Role

- Leading their most advanced product to market as EU Lead

- MAA Submission date expected soon

- Chance to register a first of it's kind product

- EMA Point of Contact related to relevant product

- Line management of 1 person initially and contribution to the shaping of the EU RA team

- Working on the EU Early Access program

- Provide regional support to global product support team

- Working on CTAs/PIPs/Briefing documents

- Defining innovative strategies for working with EU Regulatory Agencies to increase the predictability of regulatory approval

 

Experience

- 10+ years regulatory affairs experience in drug development

- Experience with PIPs (Preferable)

- Innovative product experience (Preferable - such as ATMPs/MAbs/Vaccines/etc.)

- Strong EU Experience

- Track record of taking and succesfully achieving a product to market

 

For further information or to apply, please email lewis.hogan@hobsonprior.com or drop me a call on 0333 5777 578. 

 

 

 

 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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