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Senior Regulatory Associate - CMC

Employer
Proclinical Staffing
Location
London, Uxbridge, England
Salary
Negotiable
Start date
24 Feb 2021
Closing date
10 Mar 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Proclinical are in partnership with a pharmaceutical company in search for a Senior Associate Regulatory Affairs CMC. The Senior Associate Regulatory Affairs (CMC) will provide product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle. Support may include organising, managing and executing on regulatory CMC projects and submissions.

You will be expected to create and maintain submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.

Skills and Requirements

Degree in life sciences, biochemistry, or chemistryProficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;Strong organisational skills with attention to detail;Excellent time management skills and ability prioritise workload;Project management skillsExperience in CMC, including preparation of submissions to AgenciesAdept interpersonal and communication skills (both verbal and written);Ability to work both independently and as a member of a team.

To Apply

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

#LI-PD1

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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