Registration Scientist - Regulatory Affairs
Remedica
Limassol, Cyprus
Role
The successful candidate will be able to obtain approval for new pharmaceutical products and ensurethat approval is maintained for as long as the company wants to keep the product on the market in Cyprus and abroad.
Duties and Responsibilities
Obtain new Marketing Authorizations, Maintain existing MAs and Manage and report regulatory information by:
- Compiling regulatory documents according to the requirements of each country.
- Preparing registration dossiers according to CTD or any other relevant format
- Maintaining product life-cycle and regulatory compliance by submitting MA renewals and variations
- Keeping up to date with changes in regulatory legislations and guidelines
- Liaising and negotiating with regulatory authorities and external associates
- Liaising with Contract Research Organisations for designing and performing in-vivo studies
- Keeping accurate records and report promptly currently approved information to the relevant departments within the company thus ensuring regulatory compliance
Qualifications, Skills and Experience
- University degree in Pharmacy, Pharmacology or relevant field.
- Previous relevant experience of at least 2 years in the field of Regulatory Affairs or in the pharmaceutical industry.
- Knowledge of the regulatory framework of the industry.
- Very good knowledge of English language.
- Strong analytical, communication, organisational skills.
- Computer literacy.
