Вакансия Regulatory Affairs Supervisor в городе Москва
Код вакансии: 63c902c68337720011def89b
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  • Полный день

Regulatory Affairs Supervisor

The largest international company has opened a competition for the position of Regulatory Affairs Supervisor


Responsibilities:

  • Registration Strategy development;
  • Participation in budget development;
  • People management (1 employee);
  • Perform registration and certification/declaration processes for medical devices;
  • Request documents from the manufactures, dealing with the databases, share points or other sources;
  • Prepare the dossiers for registration/ re-registration in a timely manner to meet the Workplan;
  • Ensure timely registration of products and obtaining of the relevant licenses;
  • Review product registrations for accuracy and completeness of documentation;
  • Strong cooperation with the outsoursing companies and internal stakeholders;
  • Local RA and QA Audits attendance;
  • Maintain and update RD Database: enter new documents to DB and notification of all concerned parties (upon appropriate mailing list);
  • Certificates tracking and updates in a timely manner according to business needs;
  • Dossier archiving;
  • Copy clearance of labelling and promo materials;
  • Execute trainings in a timely manner;
  • Develop strong relationship with the key stakeholders;
  • Participation in official conferences and seminars;
  • Participating in regular updates/ calls with the GRA and regional RA colleagues;
  • Change assessment for product’s changes and new regulation impact assessments.


Requirements:

  • Higher education (Engineering background is a strong advantage);
  • Relevant experience in RA field within pharma / MD company;
  • Knowledge of English language Upper-Intermediate (business communication verbal and written);
  • Communication skills: collaborative approach, open-minded, result-oriented, open for a new experience and strongly dedicated to meet the goals
  • People management;
  • Project management skills.


Benefits:

  • Competitive salary and bonus system;
  • Medical and life insurance;
  • Meal allowance;
  • Fitness compensation;
  • Mobile allowance;
  • Opportunities for professional development and growth.
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