Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Provide Regulatory Affairs assistance for the assigned product portfolio (MP, MD, FS, cosmetics), which includes engaging with authorities, managing local document provisions, overseeing procedures, updating artwork, revising product information, handling translations, and maintaining systems and databases.

• Offer Regulatory Affairs support to other affiliate functions.

• Evaluate advertising and promotional materials to ensure compliance with regulatory standards.

• Adhere to the standard operating procedures established by Biomapas/Client, remain updated on changes, and participate in relevant training sessions.

• Guarantee prompt reporting and updating of regulatory information within Client systems.

• Assist the team during audits and inspections.

• Provide Regulatory Intelligence.

• Assist Biomapas Clients with additional Regulatory Affairs tasks, offering both strategic and operational regulatory guidance.

⛳️ Requirements

• A university degree in Life Science or a related pharmaceutical field (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering).

• Proficiency in English and Bulgarian.

• A minimum of 2 years of experience in Regulatory Affairs pertaining to medicinal products, medical devices, food supplements, and cosmetics.

• Strong attention to detail and excellent time management abilities.

• Effective communication and writing skills.

• Problem-solving abilities, with a capacity to work autonomously as well as collaboratively within a team.

🏝️ Benefits

• An international team and work environment.

• Opportunities for professional development and career advancement.

• Annual performance-based bonus.

• Additional bonus system, including an Instant Reward and Recognition program.

• Personal accident and business travel insurance.

• Additional health insurance coverage.

• Influenza vaccinations.

• Rewarding referral policy.

• Workplace establishment allowance.