Senior Regulatory Consultant

Employer
Proclinical Staffing
Location
Surrey, England
Salary
Negotiable
Closing date
24 Sep 2020
You need to sign in or create an account to save a job.

A fantastic vacancy has become available for a Senior Regulatory Consultant in Surrey. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.

Job Responsibilities

    Provide regulatory input to commercial strategic and operating planning process. Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Work with above country regulatory strategists (AC-RS) to provide country input into Global and European Regulatory Strategies as required. Seek to improve alignment of local and regional regulatory strategy and tactics. Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers. Manage and Submit Marketing Authorisation Applications: National/MRP/Decentralised MAA: Manage and Submit MA Variation Applications Prepare agreed Module 1 documents in partnership with above-country operational hubs. Lead MRP/DCP submission review and planning where country is RMS, in conjunction with AC-RS Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations. Manage Clinical Trial Approvals (if performed in country

Skills and Requirements

    Life sciences or chemistry graduate to honours level or equivalent Master's Degree, Post Graduate Diploma or PhD preferred Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs) Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products) Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred

Hope to hear from you soon.

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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert