Remote Pharmaceutical Regulatory Affairs Manager

About the Role

Our client is actively seeking a highly motivated and experienced Remote Pharmaceutical Regulatory Affairs Manager to lead regulatory strategies from anywhere in the country. This role is crucial for ensuring our products meet all global regulatory requirements, facilitating successful market entry and lifecycle management. You will be at the forefront of navigating complex regulatory landscapes, developing submission strategies, and ensuring compliance. This is a fully remote position, offering flexibility and the chance to impact regulatory outcomes on a global scale without the need for office presence.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations and lifecycle management in key global markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
• Act as the primary point of contact with regulatory agencies, managing communications and responses.
• Monitor regulatory changes and trends, assessing their impact on the company's product portfolio.
• Ensure ongoing compliance with post-approval commitments and regulatory requirements.
• Collaborate with R&D, manufacturing, and commercial teams to align regulatory activities with business objectives.

Requirements

• Master's degree or Ph.D. in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology).
• Extensive experience (7+ years) in pharmaceutical regulatory affairs, with a proven track record of successful submissions.
• Deep understanding of international regulatory guidelines (FDA, EMA, SAHPRA, etc.) and dossier formats.
• Demonstrated ability to manage complex projects and cross-functional teams in a remote setting.
• Exceptional communication, negotiation, and strategic thinking skills.
• Proficiency in regulatory information management systems and relevant software.

Benefits

• Highly competitive salary and performance-based incentives.
• Fully remote work arrangement with flexible hours.
• Comprehensive health, dental, and vision insurance coverage.
• Generous annual leave and paid sick leave.
• Support for professional development, including conference attendance and training.