Remote Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a proactive and experienced Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. In this vital role, you will be responsible for navigating the complex landscape of pharmaceutical regulations, ensuring our products meet all necessary compliance requirements for market approval across various global territories. You will work closely with internal teams and external partners to prepare and submit regulatory dossiers, manage lifecycle changes, and stay abreast of evolving regulatory guidelines.

This position offers the flexibility of remote work for an individual who is passionate about regulatory compliance and possesses excellent communication and strategic thinking skills, contributing significantly to the company's global market access from anywhere.

• Prepare, review, and submit regulatory submissions (e.g., NDAs, ANDAs, variations) to health authorities worldwide.
• Interpret regulatory guidelines and assess their impact on product development, manufacturing, and labeling.
• Manage post-approval regulatory activities, including annual reports, renewals, and change control processes.
• Liaise with internal departments (R&D, Quality, Manufacturing, Marketing) to gather necessary information for submissions and ensure compliance.
• Monitor regulatory intelligence and advise the organization on emerging trends and new requirements.
• Maintain regulatory documentation and databases, ensuring accurate and up-to-date records.

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Thorough understanding of international regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
• Excellent written and verbal communication skills, with a strong ability to articulate complex regulatory information.
• Demonstrated ability to work independently, manage multiple projects, and meet tight deadlines in a remote work environment .

• Competitive annual salary and performance bonuses.
• Comprehensive health, dental, and vision insurance.
• Flexible working hours and a supportive remote work culture.
• Generous paid time off and company holidays.
• Opportunities for professional development, including regulatory conferences and training courses.