Regulatory Affairs Manager

Farmavet este unul dintre cei mai experimentați furnizori de soluții pentru domeniul veterinar din România.
Portofoliul nostru include peste 3000 de produse, fabricate în România și provenite din import. Astăzi, ne adresăm unui numar de peste 7200 de clienți, afirmându-ne ca specialist în furnizarea de produse antiinfecțioase, anti-inflamatoare, antiparazitare, antiseptice, dezinfectați și detergenți, insecticide – raticide, produse cosmetice, dermatologice, hormonale, otice și oftalmice, produse pentru sistemul nervos și digestiv, reagenți și kit-uri de diagnostic, vaccinuri, vitamine, minerale și suplimente nutritive.

University degree in Pharmacy, Chemistry, Biology, Biochemistry or in other area, but pertinent with the field;
Preferably 3-5 years of experience in pharmaceutical companies as Regulatory Affairs Associate or Regulatory Affairs Manager;
Good communication skills (both written and verbal English) and interpersonal skills;
Organized with good time management skills;
Pro-active and result oriented;
Must have an eye for detail and a methodical approach to work;

Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced;
Provides regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products;
Develops regulatory strategies and implementation plans for the preparation and submission of new products;
Monitors emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Establishes regulatory priorities or budgets and allocate resources and workloads;
Manages activities such as audits, regulatory agency inspections, or product recalls.
Participates in the development or implementation of clinical trial protocols;
Provides responses to regulatory agencies regarding product information or issues;