Manager / Sr Manager Regulatory Affairs– UK Markets

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

As part of our further expansion and growth plans, we are looking to hire Manager / Sr. Manager Regulatory Affairs an aggressive / dynamic Regulatory Affairs Professional.

This position is based at our R&D center at Turbhe Navi Mumbai and will report to the AGM - Regulatory Affairs

The remuneration package will be commensurate with the incumbents professional experience and will be in line with market standards.

Essential skills and experience:

The incumbent must have min. 10-15 years experience in the pharmaceutical industry with a minimum of 10-15 years experience handling Regulatory compliance across the European and UK market.

Specifically, the incumbent will be responsible for:

• 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.

Other responsibilities:

• 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 lifecycle management

Preferred Education requirements:

Masters in pharmacy, or Regulatory Affairs.

Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.