MSD Senior Regulatory Affairs Specialist 

Turkey 

174315286

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.