Pharmaceutical Regulatory Affairs Associate

About the Role

Our client is seeking a diligent and organized Pharmaceutical Regulatory Affairs Associate to support their compliance initiatives in Welkom . This role is crucial for ensuring that pharmaceutical products meet all local and international regulatory standards throughout their lifecycle. You will assist in the preparation and submission of regulatory documents, maintain regulatory filings, and stay updated on evolving regulatory landscapes. The ideal candidate is detail-oriented, possesses excellent analytical skills, and thrives in a dynamic regulatory environment, contributing to the successful market access of vital medicines.

Key Responsibilities

• Assist in the preparation, review, and submission of regulatory dossiers (e.g., CTD, IND, NDA).
• Maintain regulatory databases and ensure the accuracy of product registration information.
• Monitor and interpret changes in regulatory requirements and guidelines impacting the company's products.
• Liaise with regulatory agencies as needed to respond to queries and facilitate approvals.
• Support the review of labeling, promotional materials, and advertising for regulatory compliance.
• Collaborate with internal teams (e.g., R&D, Manufacturing, Marketing) to ensure regulatory requirements are met.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 1-3 years of experience in pharmaceutical regulatory affairs or a closely related field.
• Familiarity with global regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA).
• Strong understanding of the drug development process and pharmaceutical manufacturing principles.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple tasks, prioritize effectively, and meet deadlines.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance plans.
• Paid vacation, sick leave, and public holidays.
• Professional development opportunities and training in regulatory affairs.
• A collaborative work environment with exposure to diverse regulatory challenges.