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Job Details

Senior Regulatory Project Manager

Company: Regulatory Professionals
Location: South East
Reference: J31008
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: £50,000 per annum

Job Summary:

Senior Regulatory Project Manager Regulatory Professionals is currently recruiting for a Top 5 UK pharmaceutical company that specialises in the manufacturing of addiction, pain and critical care products.


Senior Regulatory Project Manager
Location: High Wycombe
Salary: £50,000 per annum
Reference: J31008

Regulatory Professionals is currently recruiting for a Top 5 UK pharmaceutical company that specialises in the manufacturing of addiction, pain and critical care products. The company vision is to expand on their international presence and become European leaders for the treatment of these areas to help patients around the world gain access to quality, affordable medicines.

The successful applicant will be reporting to the Deputy Head of Regulatory Affairs. They will be responsible for overseeing the day-to-day regulatory activities whilst project managing the high quality documentation for new EU product licenses and liaising with the relevant departments to ensure submission deadlines are met, as well as being the point of contact between the regulatory authorities and company.

Further responsibilities are outlined below:
* Marketing authorisation applications and variations/renewals for existing authorisations.
* Answer questions regarding post approval submissions and clinical trial applications.
* Preparation of product labelling texts and leaflets.
* Review and approve all artwork for use in submission and production.
* Publish submissions in eCTD and NeeS format.

The ideal candidate will possess the following qualifications/experience:
* Must be educated to degree level, ideally in Chemistry, Life Sciences or Pharmacy.
* Minimum of 7 years Regulatory Affairs experience.
* Good knowledge of the CTD dossier writing especially Modules 1-3.
* Experience of the software used for submissions in eCTD format.
* Have good Microsoft Office and Adobe Acrobat skills.
* Excellent communication ability including being able to influence by persuasion and negotiation.
In addition to the above, analytical skills are necessary, as well as meticulous attention to detail. If you are a member of The Organisation of Professionals in Regulatory Affairs, or are eligible for membership, that is a bonus.

Alternatively, if it isn't for you then please feel free to pass on the details of anyone you know who may be interested. If we place them in a role, you'll receive £250 in vouchers of your choice.

High Wycombe, Buckinghamshire, Berkshire, Oxfordshire, Bedfordshire, Hertfordshire, South East, UK, EU, pharmaceuticals, regulatory affairs, senior officer, eCTD, life cycle, project manager, CTD, dossier, manager, NeeS

Apply for this job: Senior Regulatory Project Manager

Contact Information:

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

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