Pharmaceutical Regulatory Affairs Manager

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. 5 years in a similar position
• Academic background in biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology or medicine
• Strong Knowledge of Romanian and European pharmaceutical legislation, relevant guidelines, procedures and requirements
• Excellent written and spoken English language
• Outstanding communication and interpersonal skills
• Strong planning and project management abilities
• People management skills

• Managing the activities of Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies;
• Ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements;
• Providing expert regulatory input to strategic decision making;
• Overseeing the planning, coordination, and management of regulatory documentation activities;
• Ensuring that quality standards are met and that the deliverables meet strict deadlines and fulfil Romanian and European regulatory and quality standards;
• Developing regulatory strategies and implementation plans for new products;
• Formulating or implementing regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced;
• 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;
• Managing subordinate staff in the day-to-day performance of their jobs.

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

Laropharm is you most approachable, trustful and committed Romanian partner due to its recognized expertise in integrated pharmaceutical services:
• Research and development
• Production
• Quality Control
• Regulatory Affairs & EU Batch release
• Packaging and Registration
• Sales & Marketing

We have over 20 years experience as both manufacturer under contract & manufacturer and exporter of own products, on Romanian & international pharmaceutical markets