Regulatory Affairs Specialist - Remote

About the Role

Our client is seeking a highly skilled Regulatory Affairs Specialist to join their globally distributed team, operating in a fully remote capacity. This role is critical in ensuring that our client's pharmaceutical products meet all applicable regulatory requirements in various international markets. You will be responsible for preparing, compiling, and submitting regulatory dossiers, and maintaining up-to-date knowledge of evolving global regulations. This is an excellent opportunity for a seasoned regulatory professional to contribute to market access for innovative therapies while working autonomously and collaboratively in a virtual setting, driving compliance and strategic regulatory planning.

Key Responsibilities

• Prepare and submit regulatory applications (e.g., NDAs, MAAs, variations) to health authorities worldwide.
• Interpret and apply relevant pharmaceutical regulations, guidelines, and standards.
• Maintain regulatory compliance for existing products throughout their lifecycle.
• Liaise with internal departments (R&D, Quality, Manufacturing) and external partners on regulatory matters.
• Track regulatory intelligence and assess the impact of new regulations on company products and strategies.
• Manage post-approval changes and ensure timely updates to product registrations.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Strong understanding of global regulatory landscapes, including FDA, EMA, and other key authorities.
• Experience with regulatory submission software and databases.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Proven ability to work independently, manage timelines, and collaborate effectively in a remote team.

Benefits

• Competitive salary commensurate with experience and qualifications.
• Full remote work arrangement with provision for necessary home office equipment.
• Comprehensive healthcare benefits package.
• Generous annual leave and paid holidays.
• Professional development and training opportunities to stay current in the field.