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Job Details

Interim Regulatory Affairs Manager CMC

Company: Regulatory Professionals
Location:
Reference: J24621
Closing Date: 05 Jan 17
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

Regulatory professionals are recruiting on behalf of a well-respected and distinguished international pharmaceutical company to hire a Senior Regulatory Affairs Associate on a contract basis.

Requirements:

Role: Interim Regulatory Affairs Manager - CMC
Duration: 6 Months
Location: Wiltshire
Rate: up to £50 Per hour
Reference: J24621

Regulatory professionals are recruiting on behalf of a well-respected and distinguished international pharmaceutical company to hire a Senior Regulatory Affairs Associate on a contract basis.

About the company:
Publicly owned international pharmaceutical firm, established in the late nineties and has grown extensively to an annual turnover of over £48 Million.
This company specialises in the acquisition and licensing of pharmaceutical and healthcare products and delivering them to patients through wholesalers, retail pharmacies, hospitals and a well-respected international network of distributors.

About the role:
The interim Regulatory Affairs CMC Manager will develop and manage the Regulatory Affairs Team and maintain the product portfolio, while leading the development and implementation of optimal regulatory strategies to ensure regulatory and commercial success.
The CMC manager will be responsible for reviewing and coordinating CMC documentation and Product Information reviews within the Regulatory Affairs team. They will also be responsible for Departmental QMS activities in addition to providing Expert Regulatory advice and guidance.

About the candidate:
The optimal candidate will have experience involving:
- 5-7 years regulatory affairs experience within consumer healthcare, cosmetics or medical devices.
- Proven experience within writing and reviewing CMC related documents.
- Preparing and submitting SmPC and labelling variations.
- Updating article 31 and PSURs across European territories.
- Writing and reviewing Product Information including SmPCs and PILs
- Experience dealing with MHRA and /or EU Competent Authorities.

This is a brilliant opportunity to be part of a growing and successful pharmaceutical company and operate on a contract basis.

Key Words: Wiltshire, Bath, Bristol, Chippenham, Regulatory Affairs, Officer, Manager, Project manager, Contract, Freelance, CCDS, SmpC, PIL, EMA, CMC, Regulatory Affairs Manager, Regulatory manager CMC,

Apply for this job: Interim Regulatory Affairs Manager CMC

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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