Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

Regulatory Affairs Associate - Turkey

• Fixed Term Temporary position for up to 7 months (Maternity Leave Cover)
• Bachelors degree in Pharmacy, Chemical Engineering, Chemistry.
• Minimum 1 years of Regulatory Affairs experience in a pharmaceutical company,
• Excellent command of English (both written and spoken),
• Strong commitment to compatibility, scientific quality and integrity
• Analytical thinking
• Good communication and teamwork collaboration
• Good detail-capturing skills while working in a fast-moving environment
• Role is based in Turkey

• Submission of Health Authority applications for registered and non-registered products and follow approval process. (GMP applications, new Marketing Authorization (MA) application, renewal submissions, lifecycle activities etc.)
• Compile all required documents received from Global Headquarters and prepare submission dossiers according to local requirements and make timely applications.
• Conduct the correspondences for all registered/non-registered products and follow up the Health Authority processes.
• Assist in managing global/local projects.
• Ensure the databases are updated on a timely basis.
• Evaluate local regulations/guidance for impact to any complex submission (e.g., MA, GMP) while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.