Regulatory Affairs Manager

Employer
Touchlight
Location
Hampton (City/Town), London (Greater) (GB)
Salary
Competitive
Closing date
26 Sep 2020

View more

Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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Touchlight was established in 2008 on the conviction that society’s ever-increasing understanding of DNA would lead to its emergence as a material of the future.

Touchlight has established a revolutionary platform to enable the next generation of DNA industries. Specifically, the company has developed a novel, minimal linear vector known as doggybone DNA (dbDNA), which has demonstrated unique gene expression properties.

dbDNA is produced in a revolutionary enzymatic process that addresses the significant limitations of plasmid DNA and other DNA vector technologies.

 

Touchlight has two parallel streams:

Touchlight DNA Services (TDS) is our contract development and manufacturing organisation (CDMO), established in order to meet the immediate and growing need of global customers (and Touchlight’s own projects) for GMP grade DNA.

Touchlight Genetics is exploiting our cutting edge DNA technology and ready access to manufacturing capability to develop products to meet unmet needs. Specifically, and in the near term, we are embarking on Phase I/II clinical development programmes for both prophylactic and therapeutic vaccines.

Touchlight Genetics is seeking an enthusiastic and hands-on Regulatory Affairs Manager to help us to fulfil our clinical development ambitions. This is an exciting opportunity, to establish a Regulatory Affairs function and make a significant impact on the development pathway of emerging programmes. This individual will report to the Chief Development Officer.

 

Role description:

  • To work with colleagues in process development, production, quality, project management, pre-clinical and clinical (functions represented both within Touchlight and via external consultants and CROs), to compile IMPDs, clinical trial applications, INDs, DMFs etc. and to maintain a regulatory correspondence file.
  • To support our young and enthusiastic product development team, working with our Head of Quality, in interpreting the regulatory requirements of early clinical development and work with them to ensure data and reports meet the necessary standards of external agencies.
  • To take externally facing responsibility to regulatory agencies, including point of contact, requesting and chairing meetings, and driving the interactions to meet the needs of Touchlight Genetics.

 

Qualifications and experience:

  • A minimum of 4 years experience working in a regulatory affairs environment, in early clinical development. Since we work with a highly specialised manufacturing technology, experience in compiling IMPDs and working with manufacturing professionals is essential.
  • A highly self-motivated, flexible and quick-thinking attitude to meeting the needs of the rapidly evolving state-of-the-art field in which dbDNA is being applied. Excellent interpersonal skills are needed to bring cross functional teams together for a common goal.
  • Experience of regulatory interactions (FDA/EMA/MHRA) related to product/clinical development is essential. 
  • A working knowledge of all stages of clinical development of biopharmaceuticals and small molecule drugs is required.
  • Credibility and authority to represent the company is essential.
  • Excellent organisational, project management, budgeting and problem solving skills would be welcomed.

 

Applicants MUST be eligible to work in the UK.

Apply for this role by emailing a CV and tailored cover letter (in pdf format) below.

Due to the high number of applicants we will only contact those who we invite to interview.

THE TOUCHLIGHT STORY OUR AMBITION IS FOR OUR TECHNOLOGY TO UNDERPIN THE NEXT GENERATION OF DNA PRODUCTS.

Touchlight was established in 2008 on the conviction that our ever-increasing understanding of DNA would lead to its emergence as a material of the future.

Founder and CEO, Jonny Ohlson, has brought together a highly motivated and talented group of scientists to realise this vision. They are supported by an experienced executive management team and board that brings a wealth of experience leading life sciences companies, particularly those focused on DNA-based therapeutics.

Since its founding, Touchlight has developed, patented, scaled and evidenced a revolutionary platform to enable the next generation of genetic medicines and DNA industries.

Two arms of the company have been established to utilise the platform: Touchlight Genetics, a DNA therapeutics business developing DNA vaccine and non-viral gene therapy assets, and Touchlight DNA Services, a contract manufacturing business producing dbDNA as a critical starting material for ATMP production.

Touchlight is situated at the Morelands and Riverdale Buildings in Hampton, UK. These state-of-the-art facilities have been established in a restored Victorian water works on the River Thames.

Contact Us
  • United Kingdom
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