Regulatory Affairs Specialist-Temporary İş İlanı

QUALIFICATIONS AND JOB DESCRIPTION

JOB DESCRIPTION:

In comply with company policies/guidelines/SOPs and local regulations/laws ;

• Compile, review and prepare the registration dossiers for the new products and ensure the timely submission, and carry out all related regulatory activities during the process including deficiency letters

• Update and maintain the marketing authorizations of the products post registration including renewals, variations and all related submissions according to the current legislation requirements

• Prepare, submit and follow-up the prioritization and GMP applications

• Prepare and submit the SPC-PIL applications and ensure the implementation in timely manner

• Manage the artwork change process; review, get approvals and ensure the implementation in timely manner

• Carry out all relevant activities related to medical devices and cosmetics

• Provide the technical and operational support and give regulatory input as needed

• Follow-up the current regulations, guidance and announcements and notify within the department

• Classify and archive all regulatory documents in applicable locations specific to product

QUALIFICATIONS:

• Bachelor's degree in the relevant field (Pharmacy, Biology, Chemistry, etc.)

• Min. 4 -7 years of experience in Regulatory Affairs Departments

• Good knowledge on regulatory guidelines

• Excellent command of written & spoken English

• Proficiency in MS Office applications

• Strong follow-up, planning and problem-solving skills