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Senior Regulatory Affairs Manager

Employer
Proclinical Staffing
Location
Berkshire, England, Reading
Salary
Negotiable
Start date
17 Sep 2020
Closing date
1 Oct 2020

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

Job Details

Proclinical has partnered with a global pharmaceutical organisation in search for a Senior Regulatory Affairs Manager. This role is to ensure that marketing authorisations are obtained and are in line with the company's values and goals


Job Responsibilities

    Prepare or manage the preparation of marketing authorisation applications under supervision Prepare efficiently and submit responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval. For Centralised Applications, ensure that Global Business Units are informed of status of applications and artwork is developed to support product launche Prepare and submit, according to agreed timelines, the necessary documentation to the regulatory authorities to maintain and update existing marketing authorisations, under supervision, to ensure continued development of existing products. Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and act, as agreed with supervisor, to secure regulatory approval where necessary


Skills and Requirements

    Life sciences or chemistry degree with proven relevant experience within regulatory in the pharmaceutical industry (country affiliate role for UK & Ireland Comprehensive understanding of licencing processes for marketing authorisations, particularly via the EU Centralised Procedure, and submission to regulatory authorities Significant post-licencing experience with an understanding of lifecycle maintenance for pharmaceutical products, including variations and renewal An understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure An understanding of clinical trials and early clinical development of new medicines is desirable

We hope to hear from you soon.

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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