Pharmaceutical Regulatory Affairs Manager

Employer: LAROPHARM
Domain:
  • Chemistry - Petrochemistry
  • Quality Control
  • Pharmacy - Health
  • Job type: full-time
    Job level: Manager
    Location:
  • BUCHAREST
  • Ilfov
  • Updated at: 12.04.2021
    Short 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.

    Requirements

    • 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

    Responsibilities

    • 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.

    Other info

    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