Manager Regulatory Affairs

Role & responsibilities:

• Responsible for filings of MA applications for EU and UK market
• Responsible for preparation of checklist for documents required for initial submission for EU and UK market
• Responsible for review of new projects documents for EU and UK market
• Responsible for review of documents like specification, MFC, MPR, Vendor documents and submission related documents
• Responsible for handling of comments received from Regulatory Authority of EU and UK
• Co-ordinate with various departments like Formulation and manufacturing plant for filing documentation/ customer query
• Provide dossier for online audit to concerned customers. Submitting response to due diligence and the proceeding activities.
• Coordination with API supplier for regulatory activities.
• Co-ordinate with Packaging development department for Product information and artwork preparation/ updation for new/ approved products
• Co-ordinate with various consultant for activity related initial submission and query response.
• Responsible for change control review, approval and maintenance in particular folder.
• Updation of product approval status, monthly status, variation tracker, change control tracker etc.
• Maintenance of Documents in particular Folder
• Maintain and follow-up of Invoice and entry of Invoice in Excel Sheet
• Preparation of list for pending payment and future invoices.
• Co-ordinate with account department to make sure that payment completed on time and avoid Penalties.
• Review of Agreement
• eCTD uploading and submission
• EU life cycle management

Preferred candidate profile:

Educational Qualification: M pharm

Experience: 10 to 15 years experience candidate handling EU / UK Countries.

Interested candidate can share there resume on Mail :- vaishnavi.k@umedicalabs.com