Executive/ Senior Executive

Role & responsibilities

Hiring candidates with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into -

• Preparing submission content plans for CMC submissions including, post approval changes, renewals, product renewals, Module 3 baselines, and annual report/notifications.
• Execute regulatory team activities as directed to achieve submission approval for products in regulated and semi regulated regions.
• Review quality documents for post approval submissions as above.
• Author high quality Module 3 and Module 2 section /summaries.
• Maintains the general knowledge of CMC/M3 regulations and guidance for Injectables.
• Coordinate with stake holders (R&D, Plant and suppliers) for sourcing of documents and review of executed documents received.
• Perform data entry within the regulatory databases.
• Report and escalate incidents as situation demand.
• Carry out the activities as per assigned by the immediate supervisor from time to time, for which he/she is authorized as per the SOP trainings.
• In depth understanding of Health Authority expectations for pharmaceutical types for the regulated and semi regulated regions.
• Must possess organization skills, time management skills and attention to details.
• Must possess strong communication skills, critical thinking, interpersonal skills and interpretation skills.
• Should understand business presentation and communicate descriptions of problems and solutions.

Preferred candidate profile

• M Pharm, M Sc or B Pharm with min. 2 to 6 years experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions.
• Work experience into sterile/ parenteral products would be an added preference.