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Job Details

Director of Regulatory Affairs

Company: i-Pharm Consulting
Location: Spain
Reference: BO16
Closing Date: 24 Nov 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Director of Regulatory AffairsGreat opportunity for an experienced Regulatory professional to join a Regulatory Consultancy at the forefront of Gene Therapy who have been recognised for their support in providing Consultancy advice for the first gene therapy product approval in Europe.This role would be ideal for someone with a strong biologics background looking to move into a Senior position in a very well respected Regulatory Consultancy. ...

Requirements:

Director of Regulatory Affairs

Great opportunity for an experienced Regulatory professional to join a Regulatory Consultancy at the forefront of Gene Therapy who have been recognised for their support in providing Consultancy advice for the first gene therapy product approval in Europe.This role would be ideal for someone with a strong biologics background looking to move into a Senior position in a very well respected Regulatory Consultancy.

Job Title
Regulatory Director / Associate Director (dependent on experience)

Location - Anywhere in Europe

Company Background
A Regulatory Consultancy specialising in providing Regulatory advise to some of the industry leading BioPharma companies. Recognised as one of the leading Regulatory Consultancies in the industry, they have experienced significant growth year on year to become one of the leading players in Regulatory CMC. They are Looking to expand to mainland Europe so this would be a brilliant chance for someone to establish an office and help build a Regulatory team.

Key Requirements
• Support companies in scientific advice at competent national authorities. Provision of advice, briefing document writing and meeting attendance
• Provide leadership in scientific advice meetings at national agencies and EMA
•Lead EMA procedures including orphan applications, PIPs and MAAs
• Point of contact for agency interaction.
• Provide EU regulatory strategy.
• Coordination of CMC packages to support due diligence, gap analysis and divestiture
• To lead regulatory and technical product development support to clients
• To guide, manage and lead direct reports and other staff in assigned matrix teams
• To provide management support to early stage and clinical development

About you
• 5+ years broad & deep European regulatory affairs experience with Biologics/ATMPs
• Biologics/ATMP regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
• Strong understanding of the regulatory environment including guidelines
• Ability to lead team members in a matrix management environment
• Ability to work under pressure and achieve timely submission and regulatory approvals


Benefits
Very Competitive Salary / Bonus / Pension

To Apply
If you would like to discuss this vacancy further, please submit your CV to nbehan@i-pharmconsulting.com OR call Regulatory Team Leader Niall Behan on +44 (0)20 3189 0463.

About i-Pharm Consulting
i-Pharm Consulting is a specialist recruitment company focused on mid to high-level roles in Regulatory Affairs. We recruit for both permanent and contract staff across the UK & Europe. Our clients include Pharmaceutical, Biotechnology, Contract Research and Medical Device companies www.i-pharmconsulting.com

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Apply for this job: Director of Regulatory Affairs

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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