Remote Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a diligent and experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This fully remote position allows you to contribute to ensuring our pharmaceutical products meet all necessary regulatory requirements worldwide from your home office. You will be responsible for preparing, reviewing, and submitting regulatory documentation for new drug applications, variations, and renewals. This role is critical in navigating the complex global regulatory landscape and ensuring timely market access for our life-saving medicines. The ideal candidate is meticulous, possesses excellent communication skills, and thrives in a virtual, collaborative environment.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers (e.g., CTD, eCTD) for product registrations, variations, and renewals in various international markets.

• Interpret and apply global regulatory guidelines (e.g., FDA, EMA, SAHPRA) to company projects and submissions.

• Liaise with health authorities, responding to queries and managing the regulatory submission process.

• Review product labeling, marketing materials, and internal documentation for regulatory compliance.

• Conduct regulatory intelligence activities to stay updated on evolving regulations and advise internal teams.

• Support post-approval lifecycle management of pharmaceutical products.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline; Master's degree preferred.

• Minimum of 4 years of experience in pharmaceutical regulatory affairs.

• In-depth knowledge of global regulatory submission requirements and processes.

• Familiarity with drug development pathways and lifecycle management.

• Excellent written and verbal communication skills, with a strong command of regulatory language.

• Proficiency in regulatory information management systems and document management tools is a plus.

Benefits

• Competitive salary and performance-based bonuses.

• Fully remote work arrangement with flexibility in working hours.

• Comprehensive health and wellness benefits package.

• Opportunities for continuous learning and professional development in regulatory science.

• A collaborative and supportive virtual team environment.

• Contribution to bringing essential medicines to patients globally.