Technical Responsible Manager (Mesul Müdür)

Devicare İlaç Kozmetik A.Ş.

Devicare Türkiye | Pharmaceutical Industry – Urology

About the Position

• Devicare S.L., headquartered in Barcelona, Spain, is an international company focused on developing innovative solutions in the field of urology and urinary health. As part of its international operations,Devicare Türkiye, the Turkish subsidiary of Devicare S.L., is seeking aResponsible Manager (Mesul Müdür) to oversee the regulatory, importation, quality compliance and product release activities related to its pharmaceutical products in Türkiye.

• The Responsible Manager will play a key role in ensuring that our pharmaceutical operations comply with applicable Turkish pharmaceutical legislation and the requirements of the Turkish Ministry of Health and the Turkish Medicines and Medical Devices Agency (TİTCK)

• The position will work closely with our Regulatory Affairs Consultant in Türkiye while maintaining direct communication and reporting with our international headquarters, manufacturers and relevant business partners.

Key Responsibilities

• Manage and follow up regulatory submissions and procedures for imported pharmaceutical products before the Turkish Ministry of Health, TİTCK and other relevant regulatory authorities.

• Oversee marketing authorization, variation, renewal, notification, approval and other applicable regulatory procedures, ensuring that all required documentation is complete, accurate and up to date.

• Oversee the importation process of pharmaceutical products and perform the required product/batch release activities following importation, in accordance with applicable regulations, approved product specifications, quality requirements and internal procedures.

• Review and verify relevant batch and quality documentation, including Certificates of Analysis (CoA), batch documentation, quality certificates and other required supporting documents prior to product release.

• Ensure that imported pharmaceutical products meet all applicable regulatory, quality and documentation requirements before being released and placed on the Turkish market.

• Ensure compliance with applicable requirements governing the importation, release and placing on the market of pharmaceutical products in Türkiye.

• Monitor company activities to ensure ongoing compliance with applicable pharmaceutical legislation, quality standards and regulatory requirements.

• Coordinate official submissions, correspondence, applications and communications with the Ministry of Health, TİTCK and other relevant authorities on behalf of the company.

• Work closely with the company’s Regulatory Affairs Consultant  on marketing authorization, regulatory submissions, importation, variations, renewals, regulatory compliance and other authority-related matters.

• Coordinate the exchange of information and documentation with the Regulatory Affairs Consultant and ensure timely follow-up of regulatory requirements and required actions.

• Monitor changes in Turkish pharmaceutical legislation and regulatory requirements, assess their potential impact on the company and its product portfolio, and communicate necessary actions to management.

• Ensure that regulatory dossiers, technical documentation, product records and official documentation are properly maintained and kept up to date.

• Report directly to the relevant management team at international headquarters and conduct meetings, presentations, correspondence and reporting in English.

• Support and coordinate internal and external audits and ensure that all required quality and regulatory documentation is readily available.

• Contribute to the continuous improvement of the company’s regulatory compliance, quality and pharmaceutical importation processes.

Qualifications

• University degree in Pharmacy or Medicine

• Fulfilment of the applicable professional and regulatory requirements to serve as a Responsible Manager (Mesul Müdür) under Turkish pharmaceutical legislation.

• Minimum of 2 years of professional experience in the Quality Control department of a pharmaceutical manufacturing facility.

• Strong knowledge of applicable Turkish pharmaceutical legislation and TİTCK regulations and requirements

• Knowledge and/or professional experience in Regulatory Affairs, marketing authorization, pharmaceutical importation, quality processes, product/batch release and regulatory submissions

• Good command of written and spoken English with the ability to communicate effectively in an international business environment.

• Ability to communicate directly with international headquarters, manufacturers and business partners and to prepare professional reports and correspondence in English.

Reporting & Working Structure

• The Responsible Manager will be part of  Devicare Türkiye and will take an active role in managing the company’s regulatory, pharmaceutical importation, quality compliance and product release activities in Türkiye

• The position will work in close coordination with the company’s Regulatory Affairs Consultant and will maintain direct communication and reporting with the relevant management team at international headquarters.

• The successful candidate will be expected to effectively manage interactions with Turkish regulatory authorities, oversee pharmaceutical products throughout the process from importation through release and placement on the market, and maintain professional communication in English with international teams, manufacturers and management.