Regulatory and Market Access Manager

Berko İlaç ve Kimya San. A.Ş.

Berko Pharmaceuticals, founded in 1984 by Pharm. Berat Beran, who started his career in 1970s as a pharmacist, continues to produce and work for human health. Berko Pharmaceuticals, with the vision of "Being the first and only in the special path of its choice”, has brought innovative products to the service of medicine.

Serving with 140 products and nearly 800 employees, Berko Pharmaceuticals, manufactures for a healthy future.

To support our continuous growth and reinforce our team we are looking for a Regulatory and Market Access Manager.

• Bachelor’s degree from Pharmacy, Science or related Engineering faculties,
• Min 12 years of experience in pharmaceutical licensing with 8 years in the field as a manager,
• Expert in Licensing Legislation,
• Good knowledge of English,
• Proficient in using MS Office programs,
• Driver's license and active role,
• No restrictions for frequent travelling,
• Military Service must be completed for male candidates.

Job description

• Managing the Out-Licensing Team: Supervising the Out-License Ass. Managers/Chiefs and Specialists
• Visiting markets and explore potentials for the business while presenting the company & company potentials
• Executing market research and intelligence to discover potential opportunities for Out-Licensing in the assigned international territory
• Preparation and follow-up in accordance with the information given by the R&D invoice and the application format by the Ministry of Health,
• Programmed/export-import/export-import/export inspection and follow-up in accordance with the license application format,
• Production/export preparation, preparation in accordance with the relevant legislation
• Preparation of variation applications,
• License transfer, conversion processes and updates of files,
• Preparation of SPC-KT-Label,
• Planning and bringing back to life the software of the Ministry of Health, revisions and requests for all sent products,
• Planning and tracking of variables controlled by the quality process
• Sales of GATA licensed sales permits and reimbursement applications, such as (SGK) SGK (SGK) Medical Academy,
• Making and complying with the announcements related to the legislation by the Ministry of Health,
• Conveying approvals and authorizations to cause them to have the ministry of health,
• Sales of licensed treatments, pharmacovigilance applications, and license purchases and follow-up,
• National and international training follow-up related to the license,
• Follow-up of letters from the Ministry and other official institutions and organizations,
• Compliance of GMP controls,
• Responsible for pricing responsibility and seeking approval from general management,