Pharmaceutical Regulatory Affairs Manager

Our client, a dynamic pharmaceutical company, is seeking an experienced Regulatory Affairs Manager to lead their regulatory strategies from a fully remote capacity. This is a crucial role where you will be responsible for ensuring compliance with all relevant health authority regulations across various markets. As a remote-first organization, we empower our employees to contribute their expertise from anywhere, fostering a culture of trust and autonomy.

You will play a key role in guiding product development, submission processes, and post-market activities, ensuring that our client's innovative medicines reach patients safely and effectively. This is an exceptional opportunity for a seasoned regulatory professional looking to make a significant impact in a flexible, remote environment.

• Develop and implement global regulatory strategies for pharmaceutical product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to health authorities worldwide.
• Liaise directly with regulatory agencies, including the SAHPRA, FDA, and EMA, to address queries and facilitate approvals.
• Monitor and interpret evolving regulatory landscapes, guidelines, and legislation.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Manage post-approval regulatory activities, such as variations, renewals, and annual reports.
• Oversee the regulatory review of promotional materials and product labeling.
• Conduct regulatory intelligence activities to identify potential opportunities and risks.
• Lead and mentor junior regulatory affairs personnel as the team grows.

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 8 years of experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of ICH guidelines, CTD format, and regional regulatory procedures.
• Experience in managing regulatory aspects of product lifecycle, including post-approval changes.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Exceptional communication, negotiation, and interpersonal skills.
  
  Ability to work independently and manage multiple projects simultaneously in a remote setting.
• Fluency in English is essential; knowledge of other languages is a plus.

Our client offers a highly competitive salary, performance-based bonuses, and a comprehensive benefits package, including health insurance and retirement contributions. As a fully remote position, you will benefit from exceptional work-life balance and the freedom to manage your professional life effectively. Continuous learning and professional development opportunities are provided, along with a supportive and collaborative virtual team environment. Join a company at the forefront of pharmaceutical innovation and contribute to bringing essential medicines to patients worldwide.