Remote Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking an experienced Remote Pharmaceutical Regulatory Affairs Specialist to guide product development and commercialization through complex regulatory landscapes. This fully remote position requires a deep understanding of global and local pharmaceutical regulations, including submission processes and compliance requirements. You will be instrumental in preparing regulatory dossiers, interacting with health authorities, and ensuring that our client's products meet all necessary legal and scientific standards for market approval.

This role offers the chance to work autonomously and contribute significantly to bringing essential medicines to patients worldwide.

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities in various markets.
• Interpret and apply global and regional regulatory guidelines to product development and lifecycle management.
• Liaise with regulatory agencies, respond to queries, and manage regulatory interactions throughout the submission process.
• Monitor regulatory intelligence and advise internal teams on changes in regulations and their impact.
• Ensure compliance with post-marketing regulatory requirements, including variations and renewals.
• Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to align regulatory strategies with business objectives.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs .
• Proficiency with global regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA).
• Experience in preparing and filing various types of regulatory submissions.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects effectively in a fully remote setting and meet tight deadlines.

• Competitive salary and performance incentives.
• Comprehensive health insurance coverage.
• Home office setup allowance and regular technology stipends.
• Significant opportunities for professional development and training in regulatory affairs.
• A flexible work environment that promotes autonomy and work-life balance.