Team Leader/ Senior Team Leader

VIATRIS

7 - 12 years

10 - 15 Lacs

bengaluru

Posted:1 month ago| Platform:

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Skills Required

regulatory affairs regulatory submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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