Regulatory Associate - Drug Projects

Regulatory Associate - Drug Projects

Biotechnology Clinical Pharmaceuticals

Location Abingdon, Oxfordshire

Salary Competitive

Contract Permanent

Reference TKRegDP

Date Posted

Consultant

Apply now

Less than an hour left to apply


Regulatory Associate – Drug Projects

An exciting opportunity has arisen for an experienced regulatory associate to join a growing start-up at their site in Oxfordshire. Sitting on the Project Team, you will work across a wide variety of projects delivering against agreed regulatory strategies.

This role is a great career opportunity for a drug development Regulatory Associate who is highly motivated to succeed and enjoys the fast-moving pace that a small biotech company brings.  The regulatory associate will assist with the development and delivery of regulatory documentation for drug projects.

Some main responsibilities of the role include:

  • Working alongside the quality and technical leads write regulatory clinical trial documentation for submission to EU/US.
  • Prepare Clinical Trial Authorisation (CTA/IND) submissions and substantial amendments to competent authorities and ethics committees.
  • Prepare and review clinical trial associated documentation (including IMPDs, IBs, EudraCT, protocols and labelling)
  • Prepare briefing documentation for scientific advice meetings with EU/US regulatory authorities (including pre-IND, EOP2, pre-NDA)
  • Reviewing pertinent regulations and guidance to develop pro-active solutions to regulatory issues and challenges
  • Interaction with regulatory agencies writing and submitting orphan drug applications, PIPs, LPAD submissions

Ideally candidates will be educated to degree level (or equivalent) in relevant scientific or technical discipline. The successful applicant will have significant experience in regulatory affairs with a proven track record of writing and submitting regulatory documentation, and will be able to build strong relationships and work collaboratively both with internal team members and external CRO partners.

This is a great opportunity to join a growing company who have received significant backing, and have a real impact in shaping the company. If this sounds like the opportunity for you, apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.

 

 


Regulatory Associate - Drug Projects

Biotechnology Clinical Pharmaceuticals

Apply now

Less than an hour left to apply

Quick Apply

Already a member?

Yes, send me relevant communications
I accept the terms and conditions and privacy policy of CY Partners.


Related Vacancies

Study Director Immunobiology

Biotechnology Clinical Life Sciences Pharmaceuticals

LocationAustralia

Salaryc£40,000 - £55,000

ContractPermanent

CY Partners are working with a rapidly expanding bioanalytical services CRO in Australia, who are now looking for experienced Study Directors within Immunobiology to join their growing teams. The main responsibilities include…

Director Biometrics

Biotechnology Clinical Executive Life Sciences Pharmaceuticals

LocationAdelaide, Australia

Salary£70,000 - £85,000

ContractPermanent

We have a fantastic new opportunity for a highly experienced Biometrics and Data Management Director to join a rapidly growing CRO based in Australia. The main focus of this role is to…

Quality Assurance Officer

Chemical Pharmaceuticals

LocationDurham

SalaryExcellent salary & benefits

ContractPermanent

Quality Assurance Officer CY Partners Recruitment is delighted to be working closely with a growing life science organisation that is looking to hire a Quality Assurance Officer, ideally coming from a pharmaceutical…