Remote Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a dedicated Remote Pharmaceutical Regulatory Affairs Specialist to contribute to their global compliance efforts. Based entirely from your home office, you will play a vital role in ensuring that our client's pharmaceutical products adhere to all relevant national and international regulations. This position requires a proactive individual with a keen eye for detail, excellent communication skills, and a deep understanding of the complex regulatory landscape. You will collaborate extensively with internal teams and external agencies, navigating the intricacies of drug approval processes from a remote standpoint, ensuring our client's market access and compliance worldwide.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities such as SAHPRA and FDA.
• Monitor changes in regulatory guidelines and legislation, assessing their impact on the company's product portfolio.
• Liaise with regulatory agencies, internal departments (e.g., R&D, Manufacturing, Marketing), and external partners to ensure timely approvals and compliance.
• Provide regulatory guidance and strategic advice to project teams throughout the product lifecycle.
• Maintain regulatory databases and ensure the accuracy and completeness of all submission-related information.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related discipline; Master's degree preferred.
• At least 4 years of experience in pharmaceutical regulatory affairs, preferably with international exposure.
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission processes in key markets.
• Exceptional written and verbal communication skills, with a proven ability to draft clear and concise regulatory documents.
• Proficiency in regulatory information management systems and strong remote work capabilities, including self-discipline and effective virtual collaboration tools.

Benefits

• Competitive salary range for a remote position.
• Opportunity to work from anywhere within South Africa.
• Comprehensive health and wellness benefits package.
• Allowance for home office setup and internet connectivity.
• Engage with a global team on critical regulatory strategies from the comfort of your home.