Regulatory Compliance Manager

Istanbul (Europe) Permanent

Added 28/03/2022

  • Great Career Opportunity
  • Ability to make a quick impact and shape direction of the team

About Our Client

For our client, which exports to USA and other 52 countries, we are looking for competent candidates to work as a Regulatory Compliance Manager in their Maslak Office.

Job Description

  • Making internal end external laboratory arrangements to conduct tests that required for FDA and ANSI standarts,
  • To carry out the processes with FDA consultants both in the USA and in Türkiye,
  • 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 Regulations,
  • 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 re-register 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.

The Successful Applicant

  • Bachelor degree in Chemistry / Chemical Engineering or Faculty of Pharmacy,
  • At least 10 years of experience 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 foreign 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.

What's on Offer

  • Strong career opportunities
  • Dynamic company culture with high employee retention
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Job summary

Healthcare & Life Sciences
Sub Sector
Regulatory Affairs
FMCG (Fast Moving Consumer Goods)
Istanbul (Europe)
Contract Type
Consultant name
Doruk Cavdar
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