The successful candidate will be responsible for developing and providing support to the Regulatory Affairs function. You will provide Regulatory Affairs services to internal and external stakeholders including oversight and completion of clinical submission packages, ensuring compliance to ICH GCP guidelines, SOPS and any other relevant regulations.
Responsibilities of the Regulatory Affairs Specialist
- Prepare Marketing Authorisation (MA) Applications (and Clinical Trial Applications, where appropriate) for submission
- Provide regulatory advice and information to our Associated Companies and Licensees
- Prepare, arrange and take part in scientific advice meetings with authorities
- Manage the maintenance of MA’s via renewals and variations including providing advice on data requirements for variations
- Be aware of and keep up to date with current legislation appropriate to Regulatory Affairs and provide expert advice on items or issues which will affect Regulatory and RD project teams
- Proactively build relations with 3rd parties e.g. independent companies, partners
Essential Criteria
- Previous experience working with the regulatory bodies across various African countries including Uganda, Kenya, Tanzania, Mozambique, Zambia and South Africa is essential
- Bachelor Degree in Life Science or Medical Field or equivalent experience
- Previous experience working in a similar role
- Has an in-depth knowledge of legislation and relevant Regulatory Guidelines
- Excellent analytical and problem-solving skills
- Positive work style, with an approachable, flexible manner
- High attention to accuracy and detail
- IT literate particularly in relation to using databases and document management systems
- Fluency in English language
Company Information
ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assist in their key product development efforts for over a decade. At ClinTec International, we pride ourselves on providing high quality, flexible and professional services and solutions to our clients. ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnership with some of the world’s leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.