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Job Details

Regulatory Affairs Manager

Company: Regulatory Professionals
Location: Surrey
Reference: J32585
Closing Date: 08 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive

Job Summary:

Regulatory Affairs Manager We are currently assisting a Bio-pharmaceutical company who have an excellent opportunity available for a highly experienced Regulatory Affairs Manager.

Requirements:

Regulatory Affairs Manager
Permanent position
Salary: Competitive
Reference number: J32585

We are currently assisting a Bio-pharmaceutical company who have an excellent opportunity available for a highly experienced Regulatory Affairs Manager. This company is a global pharmaceutical manufacturer with a strong focus on R&D covering different therapeutic areas. The position will be focused on a high profile rare disease product which they are looking to get marketed in the not so distance future.

Responsibilities,
* Defining project and product regulatory strategy in line with commercial and company strategy, consulting with appropriate departments when necessary.
* Provide expert regulatory advice to other departments in the organisation, and regulatory support to licensing partners in the EU and other territories.
* Ensure communication of changes in business-critical legislation/regulatory guidance, and project and product regulatory status to appropriate internal and external personnel in a timely manner.
* Pro-actively identify potential obstacles to approval of regulatory submissions and manage the resolution of issues.
* The ability to understand and present complex scientific arguments.

Requirements,
* 5+ years Regulatory Affairs experience, preferably with orphan drugs in Europe.
* Excellent negotiation, verbal and written communication and interpersonal skills.
* The ability to think strategically and develop global regulatory strategy whilst balancing local/affiliate needs.
* Rare diseases experience.
* Previously worked with New MAAs.

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

Pre, Post, Approval, initial, Development, PIP, Orphan, designation, Buckinghamshire, Surrey, Berkshire, London. South, West, Sussex

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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