Manager- Regulatory Affairs

About The Position



Responsibilities

• Responsible for filings of MA applications for EU and UK market
• Responsible for preparation of checklist for documents required for initial submission
• 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
• 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
  

Requirements

• Education: B.Pharm/ M.Pharm
• Preferred: Specialty Degrees in Analytical Chemistry, Formulation & Development, Pharmaceutical Technologies
• Experience: Minimum Experience of 10- 15 years in Regulatory Affairs in Solid Oral Dosage Forms. Work experience in Quality Control and R&D will be also considered as a plus.