Novumgen was founded by a group of experienced pharmaceutical professionals with the goal of developing and producing innovative, high quality medicines. The company quickly established itself as a leader in the UK market, and soon began licensing its products in other countries around the world.
Post : Executive / Sr. Executive - RA
Work Location : Vadodara
Job Description
• Regulatory expert responsible for the submissions, RFIs and compliance activities for pharma development and commercial products supporting Business Unit.
• Leads the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops mitigation plans.
• Provide regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities, for regional products registered specifically for EU/AU/CA/UK markets.
• Acts as the global regulatory representative within cross-functional teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic regulatory decisions.
• Accountable for interactions with regulatory agencies and external partners either directly or in conjunction with other stake holders.
• Operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.
• Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems. May take appropriate risk to achieve desired results.
Interested candidates can share their CV on isha.patel@novumgen.uk
Last Date : 30th April 2024
See All Vododara Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
