Regulatory Compliance Specialist

Delta Kozmetik San. ve Tic.

GENEL NİTELİKLER VE İŞ TANIMI

Our company DELTA BRANDS, which was established in 1953, manufactures personal care, baby products and cleaning products in its own production facilities of 28.000 m2 in Istanbul Industry and Trade Free Zone / Tuzla.

 As Delta Kozmetik, which exports to USA and other 52 countries, we are looking for competent candidates to work as an Regulatory Compliance Specialist in our Maslak Office.

• Bachelor degree in Chemistry / Chemical Engineering or Faculty of Pharmacy,
• At least 2 years of experince in Regulatory Compliance,
• Experienced in CFR-21 Pharmaceutical, Cosmetic and Medical Device Regulation,
• Competent in Ministry of Health, European Union and US regulations,
• Fluent in English both verbal and written in foreign relations and able to use his/her English to follow foreing literature,
• Knowledge of FDA Regulation and ANSI Standarts,
• Dynamic, researcher and  strong follower of regulations, updates and publications,
• Team player, strong communication skills and solution oriented,
• Having analytical thinking ability, showing detailed approach,
• Strong communication, planning and organizational skills,
• Experienced on Project Management,
• Proficiency in MS Office programs.

JOB DESCRIPTION

• To carry out the processes with FDA consultants both in the USA and in Turkey,
• In line with the FDA Drug Rules; to control the label, claims and conformity of the formula,
• To complete product registrations new product/new formula etc. according to FDA Drug Regislations,
• To renew the registrations of our own companies and contract manufacturers of on annual basis,
• According to FDA Device Rules; to check that UDI and label rules are complied, to confirm that the subcontractors are reregister the products and to renew the annual registration of our own companies,
• Checking the compliance of the labels required for all products with the legal legislation,
• To be aware of the regulations and changes regarding the Cosmetics, Medical devices, OTC (Over the Counter) products to be placed on the market and to be exported,
• To ensure that the necessary licenses or notifications are received from the competent authorities and to have a good command of the entire licensing process,
• To have knowledge of the legal, local and commercial regulations of the United States and other countries to which the product is exported,
• To ensure that the required documents are kept by following the procedures such as license renewal, variation, license transfer, etc.,

Working in closely with the Quality Assurance Department on GMP and providing relevant support in the audits.