REGULATORY AFFAIRS SPECIALIST

Regulatory Affairs Responsibilities:

• Manage VMP registration processes per Estonian & EU legislation.

• Prepare & submit regulatory documentation for new applications, variations, and renewals.

• Store & maintain internal documentation of MAs.

• Communicate with Competent Authorities (CAs), colleagues, and partners.

• Advise management on regulatory actions.

• Handle MA applications, variations, and renewals, ensuring timely submission & compliance.

• Degree in Pharmacy, Biology, Toxicology, Medicine or other life sciences.
• Excellent written and spoken command of English.
• Competent problem analysis abilities and analytical skills.
• Accurate, precise and persuasive.
• Excellent communication / interpersonal skills with all levels within the company.
• Comfortable in to use computer programs, such as Word, Excel and other business software.
• Take decisions within the limits of competence/position, assess the consequences of decisions,and take responsibility for decisions made.

✨ Competitive salary and benefits package.

✨ Professional growth opportunities in a global pharmaceutical company.

✨ Supportive and dynamic work environment.

✨ Flexible working hours.

✨ Opportunity to contribute to innovative and high-quality pharmaceutical solutions.