Regulatory Affairs Pharmaceutical Products

Genpact; Johannesburg; On-site; ZAR 30 000 - 60 000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs professional to manage the lifecycle of pharmaceutical products. This role involves overseeing regulatory submissions, ensuring compliance with local regulations, and acting as the primary contact for health authorities. The ideal candidate will possess a strong background in pharmacy or life sciences, complemented by excellent communication and problem-solving skills. Join a dynamic team where your expertise will contribute to customer success and regulatory excellence in a fast-paced environment. If you are passionate about compliance and innovation, this opportunity is perfect for you.

Qualifications

• Bachelor’s degree in a relevant field with pharmaceutical industry experience.
• Registered pharmacist in South Africa with regulatory knowledge.

Responsibilities

• Manage local regulatory affairs lifecycle for assigned products.
• Develop submission strategies and coordinate artwork changes.

Skills

Regulatory Affairs Management

Time Management

Problem Solving

Communication Skills

Knowledge of EMEA/South Africa Regulations

Education

Bachelor’s degree in Pharmacy

Bachelor’s degree in Medicine

Bachelor’s degree in Chemistry

Bachelor’s degree in Life Sciences

Job description

Job Title: Regulatory Affairs Pharmaceutical Products

Location: Gauteng, Johannesburg | Deadline: May 30, 2025

Responsibilities

• Manage the entire local regulatory affairs lifecycle for assigned products, including variations (administrative, labeling, CMC, safety, dossier harmonization), renewals, and PSUR submissions.
• Develop submission strategies, provide RA assessments through change management systems, handle deficiency letters, and coordinate artwork changes related to lifecycle activities.
• Update Local Product Information (PI).
• Act as the primary contact for Local Health Authorities for delegated products.
• Ensure customer success throughout engagement.

Qualifications

• Bachelor’s degree in Pharmacy, Medicine, Chemistry, or a related Life Sciences discipline, with relevant pharmaceutical industry experience.
• Mandatory knowledge of EMEA/South Africa regulations and proficiency in English.
• Registered pharmacist in South Africa.
• Strong time management and organizational skills to handle multiple deadlines.
• Deep understanding of quality, compliance, and their business implications.
• Ability to independently troubleshoot and resolve issues, employing innovative solutions.
• Effective verbal and written communication skills for complex issues.
• Flexibility to adapt to changing environments and update knowledge on new processes.