Algemene informatie

Job Advert Title
Regulatory Affairs Relations Manager
Locatie
Turkije
Function/Business Area
Regulatory Affairs
Afdeling
Regulatory Affairs
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Regulatory Affairs Relations Manager


About Astellas :


At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About This Job:


Astellas is currently hiring a Regulatory Affairs Relations Manager to be based in Ankara, Turkey. The role will be reporting directly into the Regulatory Affairs Affiliate Lead Turkey.


Purpose of the Position:


  • Management of the company’s Regulatory Affairs relations with the local Health Authorities (HA), to ensure optimal and compliant registration and maintenance of the company’s full portfolio, in line with the company strategy and business priorities.
  • Develop and maintain professional relationships within the Turkish Medicines and Medical Devices Agency (TITCK);
  • Initiate, plan and manage the communication plan with HA, to share Astellas position with regards to planned changes in the regulations and/or guidance issued by HA, in line with the company strategy and priorities;
  • Submit and closely follow up the status of all Regulatory Submission Packages with HA in line with the defined planning, including product priority applications for both GMP and initial Marketing Authorization (MA) procedures; Collaborate closely with Affiliate RA Lead and other relevant stakeholders to ensure submission and/or approval within targeted timelines;


Essential Knowledge & Experience:


  • Minimum of 5 to 7 years of regulatory affairs experience with direct interaction within the Turkish Medicines and Medical Devices Agency (TITCK)
  • Hands on regulatory affairs experience (dealing with most aspects of registration) within the pharmaceutical industry is essential
  • Excellent communication skills and ability to develop and maintain good working relations with internal and external stakeholders. Turkish language skills are essential. English, preferred.
  • Team oriented and collaborative working style
  • Bachelors Degree in Life Science or equivalent by experience


Additional information:


  • Permanent Role
  • Location - Ankara, Turkey


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.