Regulatory Affairs Manager

Employer
Proclinical Staffing
Location
England, Berkshire
Salary
Negotiable
Closing date
22 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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An internationally known biotechnology company has an opening for a Regulatory Affairs Manager to represent China's products from their Berkshire office. This company has a strong reputation for developing innovative therapies.

Job Responsibilities

    Member of regulatory project team(s) representing the China for 1-3 development/marketed products Work with global clinical development and R&D teams to prepare regulatory documentation to support regulatory engagement and NDA submissions in China. Attend global regulatory, cross-functional R&D and asset level business meetings to provide strategic direction and scientific rationale for regulatory activities required to support clinical trials and marketing applications in China. Provide oversight of local operational activities required to make regulatory applications in China, via CRO and company affiliate. Maintain close collaboration and partnership with China/regional business colleagues, up to and including President of APAC, in addition to local medical and clinical operations colleagues.

Skills and Requirements

    Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. Demonstrate strong organizational skills, including the ability to prioritize personal and junior team member's workload. Demonstrate effective cross-cultural awareness and capabilities. Seeking colleagues capable and experienced enough to manage multiple and confounding activities at once. Confident to identify and acknowledge when management support is required to prioritize or drive activities to a resolution.

To Apply

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-PD1

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.

 

Contact Us
  • Eldon House
  • Eldon Street
  • EC2M 7LS
  • United Kingdom
  • 0800 988 4437
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