Ideal Candidate
Deep experience in pharmaceutical industry from a regulatory affairs perspective – min. 6 months
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.
Job Description
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
Company Description
Înfiinţată în 2001, Laropharm este o companie farmaceutică solidă, cu o dezvoltare armonioasă în domeniile pe care le abordează: cercetare, producţie şi distribuţie.
Laropharm deţine una dintre cele mai moderne fabrici de produse farmaceutice, respectând regulile privind Buna Practică de Fabricaţie (GMP) pentru producţia şi distribuţia medicamentelor.
Cu un portofoliu actual de peste 90 de produse (medicamente cu prescripţie medicală, medicamente fără prescripţie medicală - otc-uri şi suplimente alimentare), laboratoare de cercetare de cel mai înalt nivel, linii de producţie moderne şi o puternică echipa de reprezentanţi medicali şi de vânzări, Laropharm se numără printre principalii competitori autohtoni de pe piaţa farmaceutică din România.
Investiţiile companiei sunt concentrate spre îmbunătăţirea şi extinderea portofoliului de produse, având ca principal obiectiv satisfacţia consumatorilor şi susţinerea unei vieţi sănătoase.
