Regulatory Affairs Specialist

ABOUT US

STADA is leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner for more than 120 years. With our products we help people protect and regain a dignified and able life. With our proven Generics, we ensure that everyday health remains affordable.

OPPORTUNITIES

To our employees we offer an attractive working environment in which they can develop personally, improve professional skills and gain valuable experience. If you are an agile, target-driven and enthusiastic person, our company will let you achieve your potential in the role of Regulatory Affairs Specialist.

RESPONSIBILITIES WILL INCLUDE:

• Carrying out and support of the procedures of registration, re-registration, introduction of changes in the CIS countries and new markets.
• Communication with the contractual counterparty.
• Preparation of application forms, registration forms, drafts of instruction for medical usage, statements, letters, variation dossiers;
• Ensuring optimal support to key stakeholders to provide on-time high quality documents in compliance with requirements;
• Coordination of procedures according to the plans;
• Preparation of administrative documents: legalization, translation requests, archives;
• Participation in GMP-inspection.

WE EXPECT FROM YOU:

• University Degree in Biotechnology, Pharmaceutics, Medicine ;
  

• English - Upper-Intermediate;

• Experience in similar position of different types of registrations;
• Strong interest for regulatory issues, integrity and strong feeling for ethics.

WE WOULD LIKE TO OFFER YOU:

• Competitive remuneration;
• Life and health insurance;
• Experience in value driven international company;
• Opportunities for professional growth;
• Learning environment that encourages personal development;
• Great management and supportive team.