Senior Regulatory Specialist

Manpower

We are looking for a  Senior Regulatory Specialistfor our company operating in the cosmetics and personal care sector, for which we are providing consultancy services

EXPERIENCE:

·        Min 6-8 years of experience 

·        Good  English communication skills

Position Overview - Basic Functions & Responsibility                                                                                                                                 

•        Ensures compliance with regulatory agency regulations and interpretations.

•            Prepares responses to regulatory agencies' questions and other correspondence.

•            Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines including upload of regulatory relevant information to the UTS database or to other authorities

•            Develops timelines for submissions under the direction of senior regulatory affairs staff.

•            Provides solutions to complex problems in which data analysis requires an evaluation of intangible variables.

•            Provides regulatory advice to project teams. Organizes and maintains reporting schedules for new drug / new medical device application and renewals.

•            Global Regulatory impact assessments for all changes at the manufacturing sites and ensuring submission of relevant changes if needed

•            Review (in view of compliance with regulatory requirements) and approve text drafts and artworks of labels packaging and instructions for use for assigned products. Translate and draft additional labels according to Turkish requirements.

•            Supporting the Regulatory Affairs part of audits.