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Job Details

Senior Regulatory Officer - CMC Project Manager

Company: Regulatory Professionals
Location: London
Reference: J31007
Closing Date: 14 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: £50,000 per annum

Job Summary:

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

Requirements:

Senior Regulatory Officer - CMC Project Manager
Location: East London
Salary: £50,000 per annum
Reference: J31007

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 Regulatory Affairs Compliance Manager. They will be responsible for representing Regulatory CMC in the New Product Development team and actively project managing high quality CMC for new products.

Responsibilities are outlined below:
* Preparation of CMC strategies for the expedition of EU registrations and complex post approval changes.
* Leading, planning and creating high quality CMC documentation for EU and International markets.
* Liaise with the regulatory project lead to plan the authority submissions.
* Write responses to CMC questions and update CMC Module 3 when relevant.

The following qualifications/experience is required:
* Educated to degree level in Pharmacy, chemistry or life sciences
* Minimum of 5 years of CMC based regulatory experience, including preparation of the Module 3 in CTD format.
* Good creative writing skills to aid the writing of Module 3 and 2.3 CTD dossier sections.
* Knowledge of European procedures, technical drug development and manufacturing knowledge.
* Proven ability to lead interdisciplinary teams in the planning of activities and multiple projects.
* Microsoft Office and Adobe Acrobat competency.
In addition to the above, you should have an organised and methodical approach to meeting deadlines, great people skills and a meticulous attention to detail. Membership, or eligibility to membership, of The Organisation of Professionals in Regulatory Affairs is also an advantage.

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.

East London, London, Essex, Kent, South East, UK, EU, pharmaceuticals, regulatory affairs, senior officer, CMC, project manager, CTD, dossier, manager

Apply for this job: Senior Regulatory Officer - CMC Project 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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