Senior Regulatory Affairs Specialist
CurrentResponsability Area: EMEA (Europe Middle-East Africa)- Oversees/support regulatory projects consistent with the company goals- Provides leadership and/or assistance in creating timely regulatory document packages for submissions andregistrations of new and mature products- Manages and maintain regulatory files based on regulatory and post-market requirements- Compiles, coordinates, and formats all materials required in submissions, license applications/amendments,technical file documentation and annual reporting- May have direct interaction with regulatory agencies on defined matters.- Reviews and recommends changes for labeling/promotional/advertising materials, manufacturing, marketingand clinical protocol for regulatory compliance to the appropriate regulations, as needed- Assists in the creation, evaluation, implementation and update of internal regulatory affairs policies andprocedures to ensure that regulatory compliance is maintained or enhanced- Maintains awareness, excellent comprehension and appropriate application of relevant regulations includingproposed and final rules.- Requires some supervision with latitude for independent judgment- Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments asneeded.- Participates in the review and approval of Change Orders; generates Change Order packages as needed.- Responsible for communicating business related issues or opportunities to next management level- Performs other duties assigned as needed- Use FBS tools in the daily work and became a champion in one of the FBS fundamentals
