regulatory affairs associate

şimdi başvur

iş ilanı detay

beşiktaş, ıstanbul (avrupa)
referans numarası

iş tanımı

We are looking for a "Regulatory Affairs Associate" for 18 months for our business partner which is an American biopharmaceutical company.

Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for preparation and submissions which may include technical and clinical variations, safety reports, amendments, license renewals, GMP inspection, GMP renewals and Marketing Authorization Applications.
Support the activities needed to ensure compliant labeling for the products (SmPC, PIL, packaging) and manage timely updates for assigned products.
Follow up and resolve the technical requests from the Health Authority.
Provide regulatory support to quality functions to ensure products are maintained in compliance with local requirements.
Support to ensure compliance with local law and regulation and consistency with global procedural documents.
May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments.
Ensure all systems are in place to meet all internal external requirements.
Follow up strategies of products in locally and globally.


Bachelor’s degree from reputable universities, preferably in Pharmacy, Chemistry, Biology, Engineering or related fields.
1-2 years Regulatory experience or in a related area in Healthcare industry.
Experience in and understanding of role of RA.
Good knowledge and proven experience in understanding and implementing regulatory requirements in.
Pharmaceutical / Biotech Industry including ICH requirements and regional requirements.
Must be capable of helping with the delivery of regulatory initiatives and managing submissions to the local HA.
Excellent organization skills and ability to work on several projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are required.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint,
Advanced level in written and spoken English.
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