Regulatory Affairs Specialist

About the Role

Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their established team, working entirely remotely. This position is critical for ensuring the company's adherence to all relevant national and international regulations across its product lines. You will be responsible for monitoring regulatory changes, preparing submission dossiers, and liaising with regulatory authorities to secure and maintain product approvals.

The ideal candidate will possess a strong understanding of regulatory landscapes pertinent to the company's industry and a proven track record in navigating complex regulatory processes effectively.

• Monitor and interpret relevant regulatory requirements, standards, and guidelines applicable to the company's products and operations.
• Prepare, review, and submit regulatory dossiers and applications to health authorities and other regulatory bodies.
• Manage the lifecycle of regulatory approvals, including post-market surveillance and variation filings.
• Liaise with internal departments (R&D, Quality, Marketing) to ensure regulatory compliance in product development and labeling.
• Represent the company in interactions with regulatory agencies and industry working groups.
• Maintain up-to-date knowledge of the regulatory environment and advise on strategic implications.

• Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
• Minimum of 5 years of experience in regulatory affairs, preferable within a regulated industry.
• In-depth knowledge of regulatory submission processes and requirements.
• Strong analytical skills and meticulous attention to detail in documentation and review.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in regulatory information management systems and standard office software.

• Competitive salary and performance-related incentives.
• Fully remote work environment, promoting flexibility and autonomy.
• Comprehensive health and wellness benefits package.
• Support for continuous professional development and training in regulatory affairs.
• The opportunity to contribute to product compliance and market access for innovative products.