Job Description

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Regulatory Affairs Manager

Istanbul, Turkey, Middle East & Africa

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world.  We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

In Turkey we are looking for Regulatory Affairs Manager based in our İstanbul office who will be responsible for all Regulatory activities and intelligence.

Job Responsibilities

  • Contribute to the review and provide Regulatory input for the finalization of the distribution agreement with local distributors, when applicable.
  • Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
  • Manage the planning, preparation, submission and follow-up of all regulatory applications in Turkey (variations, product renewals, site registration renewals, new registrations etc.).
  • Ensure that the regulatory file is complete and timely submitted to the local Health Authorities.
  • Act as a single contact point for Global RA, commercial and distributors.
  • Close follow-up and monitoring of all regulatory activities in Turkey.
  • Work closely with Global RA and RA MEA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
  • Work closely with commercial and supply chain to ensure the continuity of supply during the submission of changes and no business interruption of the registered products in the country.
  • Co-ordinate and revise the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
  • Establish and maintain strong and trustful relations with the Health Authorities and decision makers.
  • Support to commercial, supply chain, marketing, compliance, and other stakeholders associated with the achievement of business targets.
  • Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in Turkey.
  • Contribute to the preparation and submission of price appeal letters.

Experience & Knowledge

  • Education in Pharmacy, natural Sciences or relevant discipline.
  • At least 8 years of experience in Regulatory Affairs in pharmaceutical industry, preferably with within generics business and including solid leadership experience
  • Experience in preparation and submission of Regulatory files to the Competent Authorities in Turkey.
  • Computer literacy (MS-Office-Tools), good understanding of database and document management systems
  • Fluent level in English and Turkish both in oral and written communication.
  • Strong negotiation skills and very good ability to resolve conflicts and find solutions to problems.
  • Excellent communication skills and ability to engage with very different profiles and departments.
  • Cross-cultural awareness and ability to work across geographical markets.
  • Excellent planning and organizational skills and ability to drive the regulatory process with a sense of urgency, both internally through multi-disciplinary teams and externally through the effective use of third parties as well as effective communication and negotiation with regulatory authorities

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you! Please send us your complete application to Careers.Dubai@acino.swiss

We are looking forward to the opportunity to get to know you. Only direct applications to Careers.Dubai@acino.swiss will be processed.

Apply & Further Information

If you are interested in working for a company that offers such challenging opportunities, we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document to the following email address:

careers.dubai@acino.swiss

We are looking forward to hearing from you. Only direct applications are considered.

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