- 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 new 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