Regulatory Affairs Specialist

Laboratoires Bailleul İlaç San. Ve Tic. A.Ş.

Company:

Bailleul laboratories, an pharmaceutical company part of Giuliani Group, was founded in 1949 and is established in nearly 80 countries.

For over 75 years, we have always focused on improving the quality of life of patients, constantly seeking to innovate to bring solutions tailored to the needs of patients through quality products.

As part of our international expansion, we are recruiting a Regulatory Affairs Specialist (M/F).

You will be in charge of managing the Regulatory Affairs activities for Turkey.

You will be responsible for:

1.Managing the Regulatory Affairs:

-Define registration and submission strategy of dossiers in collaboration with Regulatory Affairs Head Quarter (Drugs, Food supplements, Cosmetics and Medical Devices)

-Ensure the Regulatory support for other departments of the company

-Manage and follow-up of all Regulatory Activities with the Health Authorities

-Be in direct contact with the local Health Authorities

-Report all requests from the Authorities to HQ and all obtained MA/approval

-Ensure portfolio’s regulatory compliance (variations, renewal, pricing etc…) in liaison with the RA Department.

-Management of RA database or follow-up table

-Manage the review and validation of all packaging materials, promotional materials, marketing and training tools for the company’s portfolio

2.Regulatory Intelligence:

-Maintain an awareness of regulatory, technological, scientific legislation and competitive surveillance

-Make declarations of interest

-Establish and follow up the legal documents required to market products

-Act as the key contact person for the departments concerned (development, quality production, marketing, sales, etc.) on regulatory topics

3.Monitoring reporting

-Ensures timely, clear communications to internal stakeholders on project status and issues

-Ensure data quality, reliability and archiving

You will also assume the relationship with the Health Authorities.

Holding a PhD in Pharmacy you have at least 5 to 10 years’ experience in Regulatory Affairs.

You have a solid understanding of the overall pharmaceutical business and knowledge in Regulatory Affairs in Turkey.

You are rigorous, have good communication and writing skills.

You are fluent in English.

Should you be interested, please send you application to recrutement@bailleul.com