Senior Regulatory Affairs Specialist; Pharmaceuticals; Remote

Our client, a thriving pharmaceutical organization known for its innovative product pipeline, is seeking an accomplished Senior Regulatory Affairs Specialist to join their team on a fully remote basis. This role is essential for navigating the complex global regulatory landscape and ensuring timely approvals for our client's pharmaceutical products. The Senior Specialist will be responsible for preparing, submitting, and maintaining regulatory filings in various international markets, ensuring compliance with all relevant health authority requirements.

This is a fully remote position, allowing the candidate to work from anywhere within South Africa , offering significant flexibility and autonomy. The ideal candidate will possess a deep understanding of regulatory strategies, excellent communication skills, and a proven ability to manage multiple complex projects in a virtual setting. This role is key to bringing vital medicines to patients worldwide.

• Develop and execute global regulatory strategies for new drug applications (NDAs), variations, and renewals.
• Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD format) to health authorities in target markets.
• Liaise directly with regulatory agencies (e.g., SAHPRA, FDA, EMA) to facilitate the review process and respond to queries.
• Ensure that all regulatory activities and submissions are in full compliance with applicable regulations and guidelines.
• Maintain regulatory compliance for marketed products, including post-approval changes and annual reporting.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, quality assurance, and marketing.
• Monitor and analyze evolving regulatory requirements and trends in relevant markets.
• Assess the regulatory impact of proposed product changes or new development projects.
• Manage and maintain regulatory databases and documentation systems.
• Contribute to the development of labeling and promotional materials to ensure regulatory compliance.
• Support the regulatory aspects of due diligence for potential acquisitions or partnerships.
• Train and mentor junior regulatory affairs professionals.

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• An advanced degree (MSc, PhD) or equivalent regulatory affairs certification is highly advantageous.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs, with a proven track record of successful submissions and approvals.
• In-depth knowledge of global regulatory requirements and submission processes (e.g., CTD, eCTD) for both new and established pharmaceutical products.
• Experience with regulatory submissions in major markets (e.g., US, EU, South Africa) is essential.
• Excellent written and verbal communication skills, with strong attention to detail and accuracy.
• Proficiency in regulatory information management systems and common office software.
• Strong analytical, strategic thinking, and problem-solving capabilities.
• Ability to work independently, manage projects effectively, and meet tight deadlines in a remote environment.
• Demonstrated ability to collaborate effectively with diverse teams.
• Must be legally authorized to work in South Africa .

Our client offers a competitive compensation package including a base salary and performance-related bonuses. Comprehensive medical, dental, and vision insurance are provided, along with a retirement savings plan. This is a fully remote position, offering the flexibility to work from any location within South Africa . Our client invests in their employees' professional development, offering opportunities for training, certification programs, and attendance at international regulatory affairs conferences (virtual or in-person as appropriate).

There are excellent prospects for career advancement within a growing global company, contributing to the launch of important new therapies. The company culture promotes innovation, collaboration, and work-life balance.