International Regulatory Affairs Executive İş İlanı
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QUALIFICATIONS AND JOB DESCRIPTION
Biofarma Pharmaceuticals is a well-established company engaged in pharmaceutical production with 75 years of experience, passion on the first day, dynamic and innovative employees since 1945. It continues to grow and create value for its stakeholders with nearly 700 employees, R&D center while exporting to more than 30 countries.
We as, BİOFARMA İLAÇ SAN. VE TİC. A.Ş, are looking for an "International Regulatory Affairs Executive”
QUALIFICATIONS
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering or Molecular Biology,
- Minimum of 2 years of experience in Regulatory Affairs Executive experience in International Markets,
- Strong written and verbal communication skills in English,
- Good knowledge on regulatory guidelines in regulated and other countries,
- Excellent communication skills, strong learning, open to teamwork and self-development,
- Proficiency in MS office programs,
- Excellent managing, following up and planning the projects,
- Preferably have knowledge of Qmex programme
- Strong analytical thinking skills
- Military service should be completed for male candidates.
JOB DESCRIPTION
- Lead International Regulatory Affairs Team.
- Coordination of registration dossiers submissions to Ministry of Health of related countries as per given timeline.
- Coordination and follow up all procedures required for preparation and submission of variations and MA renewals.
- Follow up the submitted dossiers, updates/renewals throughout registration process.
- Determine the actions to be conducting monthly teleconferences with partners.
- Follow up Qmex procedures and communication with related departments concerning Qmex actions.
- Making dossier audits.
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