Regulatory Affairs Specialist TurkeyContract type: CDI
Contact e-mail: email@example.com
Les Laboratoires Bailleul, an independent pharmaceutical group founded in 1949 and established in more than 80 countries, is currently experiencing strong international development.
For over 70 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.
For more information: http://www.bailleul.com
Due to our development, we are currently looking for a Regulatory Affairs Specialist for our Middle-East headquarter located in Turkey (Istanbul).
Reporting directly to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will be responsible for the preparation of documentation, implementing and conducting all the activities required to obtain and maintain the marketing authorizations of the products in the Middle Eastern Countries (particularly Iran and GCC Countries).
Your missions will be:
- Support distributors in the Middle East region with RA requirements (i.e. drugs / food supplements / cosmetics products /) in order to maintain the marketing authorisation and / or technical dossiers up to date to sustain products commercialisation.
- Follow-up of developments and changes in the Middle East regulatory policy rules and being in close communication with RA global team.
- Set and organise the regulatory files to fulfil the current regulatory requirements of the concerned countries.
- Check the compliance of the regulatory files with the subcontractors’ batch records and update them accordingly.
- Validate artworks of the products as per the current regulatory requirements of the concerned country.
- Gather the necessary documentation for writing and completing CTD files according to the local requirements.
- Be the key contact of the Health Authorities of the area, answer the questions and follow the necessary actions to respond to the Health Authorities requirements.
- Prepare and submit responses to questions from the Health Authorities
- Handle the preparation of all submissions of variations to the Health Authorities in a timely manner and ensure effective follow-up of all submissions.
- Ensure effective archive of submissions under data security.
- Maintain a accurate portfolio for all the countries of the area.
- Review and validate SmPC/PIL/Labelling
- Review and validate all packaging materials, promotional materials, marketing and training tools for the company’s portfolio.
- Follow-up and challenge the product transfer activities.
Holding a university degree in Pharmacy, you should have at least 3 years’ experience in a Regulatory Affairs department.
You have experience in module 3 format eCTD writing and knowledge of Regulations in Iranian and Gulf Countries is strongly preferred.
Having an excellent sense of organization and responsibility, you pay high attention to details.
You are open-minded, creative, solution oriented and are eager to learn.
You are fluent in English (both written and spoken) and Persian/Arabic tongue is a big plus.
You are also availability for domestic & abroad business trips (Turkey & Middle East & Europe).
If you are interested by this position, please send us your application to: firstname.lastname@example.org