Associate Specialist, Regulatory Affairs - Midrand at MSD

Job Description

Basic Functions & Responsibility (may not be limited to):

• Under supervision of the Country Lead/Senior Director/Director/Associate Director/Manager Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions and renewals and maintenance of local files as well as minor translations and artwork management.
• Under supervision of Country Lead/Director/Associate Director/Manager Regulatory Affairs the incumbent contributes in other regulatory tasks, as required.
• By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.

Major Activities (may not be limited to):

Administrative office routines

• Assists in compilation and submission of regulatory documents to the local regulatory authorities and – as applicable - to the Local Regulatory Authorities, related to new applications, variations, renewals etc.
• Assist in department administrative tasks, such as managing invoicing, meeting arrangements, coordinate agendas, take and circulate minutes, travel arrangements, as applicable.

Editing and labelling

• In connection with submission of MA applications and post-approval submissions assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
• Co-ordinate Electronic Medicines Compendium submissions, approvals and record keeping.
• The above-mentioned tasks are performed under supervision of Country Lead/Associate Director/Manager Regulatory Affairs and relevant persons in medical and marketing departments as well as Regulatory Affairs International, Global Labelling, Regulatory Affairs Europe, and MMD.

Qualification and Experience:

• The incumbent must have a post-secondary education in scientific science or equivalent.
• The incumbent must demonstrate basic medical and scientific understanding and knowledge. The incumbent should demonstrate basic skills and knowledge of local regulatory procedures.
• The incumbent must demonstrate good interpersonal and managerial skills, capability of problem resolution and the ability to work individually and in a team environment. Commitment, dedication to quality and the ability to handle multiple priorities simultaneously is a key condition. The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet.