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Regulatory Affairs Manager

Employer
Proclinical Staffing
Location
United Kingdom (GB)
Salary
£50,000+ / year ( DOE) benefits
Start date
11 Nov 2019
Closing date
11 Dec 2019

View more

Discipline
Clinical Research, Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

An international CRO, with global experience in over 50 countries, is seeking a dynamic, hard-working Regulatory Affairs Manager who is inspired to work amongst diverse backgrounds and perspectives.

JOB PURPOSE SUMMARY: 


The Regulatory Affairs Manager role includes the co-ordination of international submissions and the UK submissions and notifications for to The Medicines and Healthcare products Regulatory Agency and the Ethics Committees, and to the Health Research Authority for relevant NHS sites, as well as keeping up-to-date with changing regulations and guidelines in both these areas.

Regulatory Affairs Manager Responsibilities : 
To ensure that international submission and the UK regulatory and ethics submissions/notifications are completed according to the instructions of the Client, are accurate and complete, and comply with relevant Standard Operating Procedures, Good Clinical Practice, regulatory requirements and local guidelines.

KEY RESPONSIBILITIES AND ACCOUNTABILITIES
o Maintain up-to-date knowledge of international and the UK regulatory and ethics requirements
o Obtain and collate the required documentation for submissions/notifications and amendments
o Perform submissions/notifications and amendments within the agreed timelines. Follow-up with any questions/requests for additional information as required
o Ensure an outcome is received within the specified timelines
o Communicate all outcomes immediately to the Client and Study Team
o Support and oversee submission activities of others when requested to do so.
o Maintain a tracker of all submissions and amendments performed 
o Obtain approvals for import and export licenses where possible and required.
 

REQUIREMENTS

Previous experience working in similar kind of role within a CRO or a pharmaceutical company
Must be multilingual (German preferred) and be able to perform regulatory submissions independently.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Vamsi Gentela at  +44 203 056 5528 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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