Senior Regulatory Associate - CMC
- Employer
- Proclinical Staffing
- Location
- England, Uxbridge, London
- Salary
- Negotiable
- Start date
- 18 Sep 2020
- Closing date
- 2 Oct 2020
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
An exciting opportunity has arisen for a Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls.
Job Responsibilities
- Co-ordinate the preparation of high-quality CMC documents to support regulatory submissions in International regions Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals Co-ordinate the preparation of responses to CMC questions from regulatory authorities Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner
Skills and Experience
- Minimum BA in Life Science related degree 2 years of Regulatory, Compliance or related Science experience Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project Adept interpersonal and communication skills (both verbal and written) Ability to work both independently and as a member of a team.
To Apply
A full job description is available on request.
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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.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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