Pharmaceutical Regulatory Affairs Specialist

Din 2001, suntem o companie farmaceutică solidă, cu o dezvoltare armonioasă în domeniile pe care le abordăm: cercetare, producţie şi distribuţie. Misiunea noastră este să îmbunătățim sănătatea oamenilor oferind produse de calitate la prețuri accesibile, iar viziunea noastră este să devenim unul dintre cei mai puternici și de încredere producători de produse farmaceutice din România prin investiții în direcția extinderii și diversificării portofoliului de produse.

Deţinem una dintre cele mai moderne fabrici de produse farmaceutice, respectând regulile privind Bună Practică de Fabricaţie (GMP) pentru producţia şi distribuţia medicamentelor, cu laboratoare de cercetare de cel mai înalt nivel, linii de producţie moderne şi o puternică echipa de reprezentanţi medicali şi de vânzări, ne numărăm printre principalii competitori autohtoni de pe piaţa farmaceutică din România.

• Deep experience in pharmaceutical industry from a regulatory affairs perspective – min. 3 years
• Bachelor’s degree in biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology or medicine
• Knowledge of Romanian and European pharmaceutical legislation, relevant guidelines, procedures and requirements
• Excellent written and spoken English language
• Proficient use of Microsoft Office software
• Adaptability, strong planning and organizational skills
• Able to multi-task and prioritize workload in a fast-paced environment
• High attention to detail
• Self-motivated, dynamic and able to work independently and in a team.

• Overseeing the planning, coordination, and management of regulatory documentation activities
• Preparing, coordinating and supervising regulatory submissions
• Reviewing product conformance and assuring compliance
• Preparing authorization documents, reauthorization, response to requests and variations for the medical products
• Preparing the documents for notification / response to requests / updating food supplements;
• Registration and updating the cosmetic products on CPNP
• Examining, identifying, and interpreting relevant regulatory guidelines
• Maintaining contact with the National Medicines Agency (NAMMD), National Research and Development Institute for Food Bioresources, the Ministry of Health.
• Keep up-to-date with changes in regulatory legislation and guidelines developed by the National Medicines Agency, the Ministry of Health (food supplements), National Research and Development Institute for Food Bioresources (food supplements) and medical devices on the activity of Regulatory Affairs;
• Implement different strategies in order to meet evolving regulatory initiatives

We offer:
• Motivational salary package
• Private Medical Insurance
• Meal tickets
• A dynamic work environment with a culture that is open, innovative and performance-orientated