Pharmaceutical Regulatory Affairs Manager

Our client, a globally recognized pharmaceutical company, is actively seeking an accomplished Pharmaceutical Regulatory Affairs Manager to lead their regulatory strategy. This is a fully remote position, offering unparalleled flexibility while maintaining a critical role in bringing innovative medicines to market. The successful candidate will be responsible for developing and executing regulatory submissions, ensuring compliance with all relevant health authority regulations across key markets.

This role demands a strategic thinker with extensive experience in navigating complex regulatory landscapes. You will play a crucial part in shaping the future of our client's product portfolio and ensuring timely access to essential treatments for patients worldwide. This remote position requires a high degree of self-discipline and proactive engagement. You will be a key advisor on all regulatory matters, impacting product lifecycle management and market entry strategies.

• Develop and implement global regulatory strategies for new drug applications (NDAs), marketing authorization applications (MAAs), and variations.
• Prepare, review, and submit high-quality regulatory dossiers to health authorities such as the SAHPRA, FDA, EMA, and others.
• Provide regulatory guidance and expertise to cross-functional teams, including R&D, clinical development, manufacturing, and commercial operations.
• Monitor and interpret evolving regulatory landscapes and provide proactive strategic advice to the organization.
• Manage lifecycle regulatory activities, including post-approval changes, annual reports, and safety updates.
• Lead regulatory interactions with health authorities, including pre-submission meetings and deficiency letter responses.
• Ensure compliance with all applicable regulations, guidelines, and company policies throughout the product lifecycle.
• Contribute to the development and implementation of regulatory policies and procedures.
• Oversee the preparation and review of labeling and promotional materials for regulatory compliance.

• Advanced degree (Master's or Ph.D.) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• A minimum of 8 years of experience in pharmaceutical regulatory affairs, with a proven track record of successful global submissions.
• Deep understanding of regulatory requirements in major markets (e.g., South Africa, US, Europe).
• Demonstrated experience in regulatory strategy development and execution for both new molecular entities and existing products.
• Excellent knowledge of drug development processes and pharmaceutical manufacturing.
• Strong analytical, problem-solving, and communication skills.
• Proven ability to manage complex projects and lead cross-functional teams in a remote setting.
• Experience with regulatory submission software and databases.
• Ability to work independently, manage time effectively, and meet aggressive deadlines.
• Must be able to work remotely and maintain high levels of productivity and collaboration.

As a fully remote position, our client offers significant flexibility and autonomy. The compensation package is highly competitive, reflecting the strategic importance of this role.

• benefits include comprehensive health and wellness programs, generous retirement planning options, and performance-driven incentives.
• We invest in our employees' professional growth through continuous training, conference attendance, and opportunities to work on challenging global projects.

This role provides the unique advantage of contributing to global health outcomes from the comfort of your home, with robust support systems in place to ensure seamless remote collaboration and success. Enjoy the benefits of working with a forward-thinking company from anywhere in South Africa .