International Regulatory Affairs Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering or Molecular Biology
- Minimum of 2 year of Regulatory Affairs experience in International Markets,
- Strong written and verbal communication skills in English,
- Second language (Russian, French) is preferable,
- Excellent communication, strong learning agility,
- Good knowledge on regulatory guidelines and procedures of regulated and other countries,
- Analytical, problem solving, presentation skills,
- Excellent follow-up, planning and organizational skills,
- Ability to manage a variety of cross-organizational projects, working closely with broad range of internal and external team
- Proficiency in MS Office applications,
- No military obligation for male candidates.
- Submission of the marketing authorization application dossiers to the Ministry of Health of the relevant countries operating in the International Markets as per given timeline and portfolio,
- Preparation and submission of renewal dossiers,
- Follow up of variation applications,
- Coordinating all activities related to deficiency letters and preparing answers properly,
- Closely following national and international regulations and legislations
- Ensuring regulatory compliance with regional laws, regulations and guidelines
- Giving support to related departments on subject related to Regulatory knowledge and procedures,
- Archiving all correspondence and documents related to the products.
