Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Centurion; Hybrid; ZAR 600,000 - 860,000; Full time

Benefits offered by this job

Competitive salary

Remote work from home

Health and wellness benefits

Home office setup allowance

Global team collaboration

Job summary

Placements24 is seeking a dedicated Remote Pharmaceutical Regulatory Affairs Specialist to contribute to global compliance from a home office. You will manage regulatory submissions, monitor changes, and advise project teams on strategy to secure market access worldwide.

This remote role requires a strong understanding of SAHPRA, FDA regulations, and international submission processes, along with excellent written and verbal communication and the ability to collaborate virtually across internal

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences required; Master's preferred.
• At least 4 years of pharmaceutical regulatory affairs experience, with international exposure if possible.
• Strong knowledge of global regulatory guidelines, submission processes, and health authority interactions.

Responsibilities

• Prepare, review, and submit regulatory documents for NDAs, variations, and renewals to SAHPRA and FDA.
• Monitor regulatory changes and assess impact on product portfolio.
• Liaise with regulatory agencies, internal teams, and external partners to ensure timely approvals.
• Provide regulatory guidance to project teams throughout the product lifecycle.
• Maintain regulatory databases and submission information accuracy.

Skills

Regulatory affairs

Remote collaboration

Regulatory documentation

Education

Bachelor's degree in Pharmacy or Life Sciences

Master's degree preferred

Job description

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.