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Job Details

Senior Regulatory Affairs Manager - London

Company: Clearwater People Solutions
Location: London
Reference: JMREG12117
Closing Date: 13 Mar 17
Type: Permanent
Salary (£): 80,000 - 100,000
Benefits:

Job Summary:

A fantastic opportunity has risen within an incredibly exciting and pioneering organisation as Senior Regulatory Affairs Manager, based in the heart of London a stone’s throw away from the Thames and within a 10-minute walk from London Bridge station.

Requirements:

A fantastic opportunity has risen within an incredibly exciting and pioneering organisation as Senior Regulatory Affairs Manager, based in the heart of London a stone’s throw away from the Thames and within a 10-minute walk from London Bridge station.

This opportunity will enable the successful candidate to be involved in taking products (Cell and Gene Therapy) into early clinical trials, providing clinical, technical and manufacturing regulatory expertise. Reporting into the Head of Regulatory Affairs, you will act as a regulatory representative whilst providing operational management to the Regulatory Group, thus supporting the Head of Regulatory Affairs in their duties. There will be a strong focus on supporting clinical trial initiatives and therefore requires strong ATMP experience in clinical trial submission.

 

Key Duties/Responsibilities:

  • Act as Regulatory Representative supporting clinical trial initiatives,
  • Support in development of CMC and Regulatory Strategy
  • Submission of regulatory documentation (briefing documents, CTAs, INDs, safety reports and annual reports)
  • Liaise closely with relevant internal departments to ensure proposed developments are fit for purpose

 

Experience and Qualifications:

  • 5+ Years’ proven experience in a regulatory role (advanced therapy, cell-based preferred)
  • Knowledge of CMC and GMP requirements for ATMPs
  • Experience evaluating and implementing regulatory strategies and any issues that may arise within biotechnology, biological therapies and preferably, advanced therapies
  • Ability to lead regulatory aspects of development strategy
  • Prior experience delivering high-quality regulatory documents
  • Demonstrable leadership of IND and CTA processes

 

Highly Desirable:

  •  Registration of Cell and Gene therapies for clinical trial throughout the UK or US

 

What is Offered:

  • Full-time career opportunity with career progression
  • Market-leading salary will be offered depending on level of experience and skills
  • Permanent contract of employment with company perks and benefits

 

 

Why this Vacancy is right for you:

  • Established and successful organisation
  • Investment in employee development.

 

Please send your application* with your most recent CV today via Pharmiweb. To find out more about this career opportunity please call Jacob Midwinter on *************** or email ******************************** detailing your interest.

If this role is not right for you, please contact us to discuss what you are looking for.

*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

 

Clearwater People Solutions are proud to offer a service based on a quality and personalised approach. We work diligently on behalf of our Candidates to find the right role that you and your specialist skill set deserve. Our consultative, honest approach combined with our integrity and full qualification of each-and-every requirement we work make us a perfect partner for you in your search for the ideal position.

At Clearwater – your Career is our Job. We look forward to hearing from you.

KEY WORDS:

IND / CTA / CMC / Regualtory Affairs / Cell Therapy / Gene Therapy / FDA / ATMP 

Apply for this job: Senior Regulatory Affairs Manager - London

Contact Information:

Address:  Head Office
Unit 19, Basepoint Business Centre, Metcalf Way, Crawley
RX11 7XX
England
Tel:  +44 (0)1293 817111
Website:  Visit Our Web Site

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