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Regulatory Associate, Drug Projects

Company: 30 Technology

The Job: 

The role of Regulatory Associate, Drug Projects at 30 Technology is a critical role in successfully delivering innovative drug development projects.  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. We are looking for an experienced regulatory affairs specialist to assist with the development and delivery of regulatory documentation for drug projects.

This role is based in Oxford, UK.

Responsibilities

  • 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 etc.

Essential Requirements

  • Bachelor’s degree in a scientific or technical subject
  • 5 years+ experience in regulatory affairs with a proven track record of writing and submitting regulatory documentation
  • Excellent written and verbal communication skills.
  • Ability to build strong relationships and work collaboratively both with internal team members and external CRO partners

 

Application details

To be considered for this exciting opportunity, please submit your CV and a cover letter to jenny.howell@30.technology

Closing date: 15th October 2019

 

About 30 Technology

30 Technology was created as a group of seven wholly owned subsidiaries aligned to its research programs and market verticals:

30Respiratory, 30Woundcare, 30Therapeutics, 30Pharma, 30Dermatology, 30AnimalHealth and 30Innovation. 

30 Technology aim to unlock and deliver the promise of therapeutic nitric oxide by developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.

Nitric oxide (NO) is a volatile gas, produced in tissues of the body, which acts as a vital cell-to-cell signaling mechanism. The discovery NO is involved in a number of critical physiological processes led to a 1998 Nobel Prize. Since then, a number of attempts have been made to harness its multiple therapeutic effects which include increased blood flow, regulation of immune response, abroad-spectrum anti-microbial activity and acceleration of healing.

However, NO has a very short half-life, so sustained release and practical delivery is difficult to attain. 30 Technology has solved these previously intractable problems, utilizing proprietary IP to create a platform technology which uniquely creates the opportunity to use NO in a variety of diseases and health conditions.

Additionally, our revolutionary 30TechnologyTM Intellectual Property allows us to deliver sustained NO into the lung via aerosol, through the skin via topical patches, gels, liquids and into the body for release from biomaterials in regenerative medicine.

Our technology is clinically proven and a potent solution to many serious medical conditions.

To achieve its goals, 30 Technology has been highly successful in its first round of funding, raising more than £30m. The lead investor is Morningside Ventures, the Harvard, Boston-based Lifescience VC with an international reputation.

 

30 Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 

To apply for this vacancy please get in touch with the recruiter using the details shown above.

Submit Vacancy

Submission Terms and Conditions

Terms and conditions for submitting a vacancy onto Milton Park’s website: www.miltonpark.co.uk

  • This job vacancy must be based only on Milton Park
  • The company must be a Milton Park occupier
  • This job vacancy will remain live for 3 months or until further notice from yourself
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