Regulatory CMC OfficerTouchlight is currently seeking a Regulatory CMC Officer to join our expanding team, reporting into our Director of Regulatory Affairs.
Touchlight is currently seeking a Regulatory CMC Officer to join our expanding team, reporting into our Director of Regulatory Affairs.
This is an exciting, fast-paced environment suited to initiative-taking individuals with scientific regulatory experience in a contract development and manufacturing organisation or related field such as gene therapy or nucleic acid therapeutics.
- Act as CMC regulatory interface with internal and external stake holders to support project activities, providing regulatory advice and documentation.
- Prepare, review, and maintain relevant CMC sections of regulatory filings. Liaise with clients to ensure rapid turnaround of review/approval process.
- Provide regulatory support in all aspects of regulatory CMC activities such as risk assessments, change controls, regulatory impact assessments and compilation of regulatory packages .
- Co-ordinate and input into writing and generation of timely responses to questions from external clients and regulatory agencies.
- Providing accurate regulatory documentation for GMP inspections, when needed.
- Support the continued growth of Touchlight’s platform technology, as required.
- Establish systems and procedures for regulatory document management and maintenance.
- Capture regulatory intelligence/evolutions in the field of regulatory affairs applicable for DNA, mRNA, ATMPs and maintain internal database
- Provide regulatory resource to cross-functional project teams
- Interpret and apply global/regional CMC regulatory guidelines
- Author or Co-author CMC dossier-centric scientific reports which will be used as basis for global regulatory submissions
- Prepare and write the CMC documentation needed for regulatory submissions
- Ensure full compliance with regulatory requirements
- Control and management of CMC modules and supporting information
- Life Sciences graduate, educated to degree level or above in molecular biology, biomedical science, biology, biochemistry, pharmacy, chemistry
- A minimum of 5 years’ experience in CMC or contract services organisation
- Familiar with regulatory CMC writing or have regulatory knowledge of (bio)pharmaceutical manufacturing and development
- Experience in compiling regulatory documents and working with development scientists, manufacturing, and/or analytical professionals is required.
- A highly self-motivated, flexible, and quick-thinking attitude to meeting the needs of the rapidly evolving state-of-the-art field.
- Fantastic opportunity to join Touchlight during its exciting growth!
- An incredible culture, which celebrates creativity and attracts, nurtures, and rewards talented employees
- A competitive C&B package
Apply using the below application form or directly to email address TDSJobs@touchlight.com with your resume attached in the mail.
Touchlight is focussed on the enzymatic synthesis of novel DNA formats. Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need for a better quality, faster and more robust DNA manufacturing technology. Our CDMO and technology is built on the conviction that DNA is fundamental to the future of medicine.