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Job Details

Regulatory Coordinator EMEA

Company: SEC Recruitment
Location: Brussels
Reference: #13012017LD
Closing Date: 20 Jan 17
Type: Contract
Salary (£): Negotiable
Benefits: TBC

Job Summary:

Main missions: • to provide procedural, administrative and planning support for new submissions and variation submissions in the EU • to provide administrative regulatory support during filing and review of new submissions, variations / to plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission • to draft module 1 components • to ensure timely submission in collaboration with managers• to prepare the English Product Information in collaborat ...

Requirements:

Main missions:
• to provide procedural, administrative and planning support for new submissions and variation submissions in the EU
• to provide administrative regulatory support during filing and review of new submissions, variations / to plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission
• to draft module 1 components
• to ensure timely submission in collaboration with managers
• to prepare the English Product Information in collaboration with WPL
• to keep up to date with EU procedural requirements and legislation
• to participate as Subject Matter Expert in relevant work projects
• to lead regional submission
• to act as the regional point of contact for Business Owners
• to interact as necessary with regional MMD planning and/or manufacturing sites regarding issues

Qualifications, Skills and Experience:
• University degree
• Excellent written and verbal communication skills in English (other languages would be a plus)
• Good understanding of the pharmaceutical lifecycle

Apply for this job: Regulatory Coordinator EMEA

Contact Information:

Address:  Head Office
3rd Floor, 13-15 Moorgate London.
EC2R 6AD
England
Tel:  00 44 (0) 207 255 6600
Fax:  00 44 (0) 1483 888997
Website:  Visit Our Web Site

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