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.
Отзывы