Remote Regulatory Affairs Specialist - Pharmaceutical Submissions

About the Role

Our client, a dynamic and rapidly expanding pharmaceutical company, is seeking a highly skilled and motivated Remote Regulatory Affairs Specialist to bolster their submission team. This is a fully remote opportunity, allowing you to contribute to global drug development from the comfort of your home office. The successful candidate will play a critical role in preparing, submitting, and managing regulatory dossiers for new drug applications (NDAs), variations, and other regulatory filings across various international markets. This position demands a comprehensive understanding of global regulatory landscapes, exceptional attention to detail, and the ability to navigate complex submission processes efficiently.

If you are a seasoned regulatory professional seeking a challenging and flexible remote role, this is an ideal opportunity to leverage your expertise and make a significant impact on bringing essential medicines to patients worldwide. Join our client's collaborative and forward-thinking team, working remotely to shape the future of pharmaceutical regulation.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers (e.g., CTD, eCTD) for drug product registration and lifecycle management in accordance with global regulatory requirements.
• Liaise with health authorities (e.g., SAHPRA, FDA, EMA) to address queries, facilitate reviews, and manage the submission process.
• Ensure all regulatory submissions are accurate, complete, and compliant with current guidelines and company policies.
• Monitor changes in the regulatory landscape and assess their impact on current and future submissions.
• Collaborate with internal departments, including R&D, Quality Assurance, Manufacturing, and Legal, to gather necessary information for regulatory filings.
• Provide regulatory guidance and strategic advice to project teams throughout the drug development lifecycle.
• Review promotional materials and product labeling for regulatory compliance.
• Maintain regulatory databases and track the status of ongoing submissions and approvals.
• Contribute to the development and implementation of departmental SOPs and work instructions.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Advanced degree (MSc, PhD) or equivalent regulatory experience is preferred.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs, with a strong focus on dossier preparation and submission management.
• In-depth knowledge of global regulatory guidelines (ICH, FDA, EMA, SAHPRA) and submission formats (eCTD).
• Proven track record of successfully preparing and filing regulatory dossiers for various stages of drug development.
• Excellent analytical, organizational, and problem-solving skills.
• Exceptional written and verbal communication skills, with a keen eye for detail.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote environment.
• Proficiency in regulatory information management (RIM) systems is a plus.
• Strong interpersonal skills and the ability to build effective working relationships with internal teams and external health authorities.

Benefits

• Competitive salary commensurate with experience and remote work arrangement.
• Comprehensive health, dental, and vision insurance.
• Generous remote work stipend for home office expenses and internet.
• Extensive opportunities for professional development, training, and attending international regulatory conferences.
• Flexible working hours to support work-life balance.
• Retirement savings plan with company match.
• Collaborative and supportive remote team culture.