Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Europe and UK market for CMC and labelling aspects.
To collate and compile current application & life cycle management CTD dossier modules from M1 to M5 for Europe and UK.
Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines.
Respond to Health Authority questions related to CMC submissions in a timely and accurate manner.
Develop and implement regulatory CMC strategies to support current MAA and post-approval changes (PACs), variations, and life cycle activities.
Co-ordinate with cross functional teams for document request, review, required for regulatory submission.
Upload and publish the documents in eCTD software required for regulatory submission.
Arranging and coordinating trainings within departments.
Critically review documentation intended for submission for internal consistency.

📌 Executive/senior Executive Regulatory Affairs Europe And Uk Market Bengaluru
🏢 Strides Pharma Science
📍 Bengaluru