Regulatory Affairs Specialist

About the Role

Our client is seeking a meticulous and proactive Regulatory Affairs Specialist to join their globally recognized pharmaceutical company, operating remotely. You will be responsible for ensuring that all products comply with the complex and evolving regulatory requirements across various international markets. This is an essential role that supports market access and product lifecycle management, requiring a keen eye for detail and a deep understanding of pharmaceutical regulations. You will work closely with internal teams and external partners to navigate the regulatory landscape, contributing to the successful launch and maintenance of pharmaceutical products.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for product registrations and variations.
• Maintain and update regulatory documentation, ensuring compliance with global standards.
• Monitor changes in regulatory legislation and guidance, assessing their impact on company products.
• Liaise with regulatory authorities to address queries and facilitate the approval process.
• Provide regulatory support and strategic advice to R&D, marketing, and other departments.

Requirements

• Bachelor's degree in a relevant scientific, technical, or legal field.
• Proven experience (e.g., 3+ years) in pharmaceutical regulatory affairs.
• Solid understanding of global regulatory requirements for pharmaceuticals (e.g., EMA, FDA).
• Experience with regulatory submission software and databases.
• Excellent written and verbal communication skills, with strong attention to detail.

Benefits

• Competitive salary commensurate with experience.
• Fully remote working arrangement, offering significant flexibility.
• Comprehensive health and wellness benefits package.
• Generous annual leave and company holidays.
• Professional development opportunities and support for further training.