POSITION REGULATORY AFFAIRS SPECIALIST

WORKING HOURS: Flexible from 08:00 to 17:00.
POSITION OBJECTIVE:
The selected candidate will be responsible for the preparation and management of DMFs, as well as communication with regulatory agencies and clients on regulatory matters.
Key Responsibilities:
Preparation of DMFs.
Submission and filing of DMFs with Regulatory Agencies (FDA, EDQM, etc.).
Maintenance and updating of DMFs submitted to the various Agencies.
Responding to deficiencies issued by Regulatory Agencies.
Managing regulatory interactions with clients.
Participation in the management of new projects with clients.
Requirements:
Education:
Degree in Chemistry or Health Sciences.
Experience:
Preferably 1–2 years of experience in areas related to quality, laboratory work, research, or the chemical industry in general, ideally within companies manufacturing pharmaceutical raw materials (APIs) or finished products.
Languages:
A very high level of English is essential.
Val...

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