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MSD Senior Regulatory Affairs Specialist 
Turkey 
174315286

07.07.2024

Job Description

Job Description

Under the direction of the Regulatory Manager, the incumbent:

  • Manages regulatory activities for new products in order to get products to market according to company plans.

  • Handles timely submission and follow-up of post-approval labeling and CMC variations.

  • Develops drives and finalizes all applications for GMP/new product registrations in line with local regulatory requirements and with marketing plans.

  • Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.

  • Handles the control of packaging components artworks developed by labeling coordinator.

  • Updates and implements local regulatory procedures in a timely manner, in close synergy with the regional organization.

  • Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.

  • Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.

  • Keeps abreast of trends and legislation, at both national and international levels.

  • Provides advice and recommendations to Management and to regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.

Requirements

  • Graduated from the Pharmacy, Chemistry, Chemical Engineering and Biology departments of universities,

  • At least 3 years of experience in the registration of medicinal products

  • Has good command of English,

  • Successful in human relations and open to communication,

Current Contingent Workers apply


*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



Job Posting End Date:07/09/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.