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Regulatory Affairs CMC – Senior Associate – Broad Portfolio

Employer
RBW Consulting
Location
United Kingdom
Salary
£40,000 - £44,000 plus great benefits package inc bonus, pension, healthcare
Start date
17 Dec 2021
Closing date
16 Jan 2022

View more

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

My client are seeking a Senior Regulatory Affairs Associate with CMC knowledge to join their International Regulatory Affairs team. This person will work alongside the Product Leads, to support pipeline and portfolio across 45 ROW countries.

In this vital role you will be responsible for the preparation of the CMC content of Clinical Trial Applications, Marketing Applications, and Post-approval Variations dossiers that comply with International country/region regulatory standards. 

You will be working within the document management system on compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation.

Key Responsibilities:

  • Responsibility for the execution of the preparation of International Clinical Trial Applications, Marketing Applications and post-market supplements/variations.
  • Work with local country affiliates to act with local regulatory authorities.
  • Coordinate timely submissions of CMC content to regulatory authorities according to local regulations.
  • Assisting in the development of regulatory strategies for submissions, while adhering to country requirements and approval processes.
  • Maintain local tracking and archival of submissions and approvals.
  • Contribute comments to Regulatory guidance documents Regulatory intelligence updates, compliance gap assessments.
  • Support the resolution of any problems on the critical path to the CMC dossier submission in concert with the CMC product representative or delegate, publishing and International regulatory.
  • Support response to questions raised by authorities.

Key Skills Required:

  • Master’s or Bachelor’s degree or equivalent
  • 1-5 years Regulatory Affairs experience
  • CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products
  • Excellent communication skills with ability to communicate across all levels
  • Strong MS Office skills.

This role will be majority work-from-home in the UK, with occasional trips to the Uxbridge or Cambridge offices required.

In return for your work, my client offer growth opportunities to learn and move up in a global organization, working in a diverse and inclusive community of belonging. They offer a generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.

Company

At RBW Consulting we provide a truly modern approach to recruitment, offering a consultancy based solution to clients and candidates alike which we believe elevates us ahead of all our competitors.  Driven by our five core values, each of our Consultants demonstrates; Growth Mindset, Professionalism, Commitment, Honesty & Fairness to provide the best services we can to everyone we work with.

With unparalleled candidate networks we are the first to hear of new and exciting opportunities in the industry.  All Consultants at RBW focus in their own vertical niche, and it is this way of working which means we can honestly say our Consultants are true experts in their field.  

Our areas of specialism are:

  • Health Economics and Market Access
  • Biometrics
  • Clinical Research
  • Medical Affairs
  • CRO Business Development
  • Regulatory Affairs
  • Data Science
  • Pre-Clinical Research
  • Healthcare Communications
  • Human Resources
  • Patient Recruitment
  • Legal & Compliance
  • Search & Selection

With coverage across the UK, Europe and the United States, RBW consistently has a range of new, exciting and lucrative opportunities on either a permanent or contract basis, from Junior right up to Board level appointments.  To find out more about any of these opportunities, or if you just want to have a general discussion about what is available to you, please call +44 (0) 1293 584 300 or email  info@rbwconsulting.com

 

icon-hub-RBWPlease visit our Careers Hub on

https://www.pharmiweb.jobs/minisites/rbw-careers-hub/

 

 

 

 

Find Us
Website:
Telephone
01293 584 300
Location
Origin Two
106 High Street
Crawley
West Sussex
RH10 1BF
GB
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