Responsible for the Life Cycle Management of assigned products according to EU regulations and other country regulations where the products are registered
Ensure compliance of products with Authority Regulations, decisions & decrees and with Quality system requirements whichever is stringent
Preparation, Compilation and submission of all the maintenance activities (Renewal & variations) based on company plans and in compliance with Regulatory Authority guidelines; address queries from the regulatory authorities and obtain the approvals
Coordinate administrative tasks such as ordering translations, legalization, CPP to facilitate submissions
Change control evaluation
Responsible for keeping Orion Internal Regulatory systems up to date and accurate
Keep the regulatory archive complete and ensure that all current licenses and labelling are up-to-date
Coordination with Internal and External stakeholders for effective implementation of the change
Follow and comply with all the defined internal policies and procedures of working
Qualification & Experience
Bachelors / Master degree in Pharmacy from a reputed College / University
Candidates must have 4+ years of RA experience
Experience on Product lifecycle management will be an added advantage
Confirmed knowledge of EU requirements and ICH guidelines
Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities will be an added advantage.