Regulatory Affairs Associate II

Watson Pharama

6 - 11 years

8 - 13 Lacs

mumbai navi mumbai

Posted:1 week ago| Platform:

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Skills Required

selection process usage regulatory affairs associate sap pharma associate ii document management regulatory affairs recruitment process management

Work Mode

Work from Office

Job Type

Full Time

Job Description

How you ll spend your day

Assessment of change controls for registration impact and implementation of all necessary dossier changes; specifically for Europe and International Market.
Responsible for compilation of the variations, renewals, RFI responses for the products in the product portfolio in collaboration with other stakeholders.
Responsible to keep trackers and database up to date.
Briefing the regulatory status in different forums associated with cross functional teams.
Experienced in managing software related to Regulatory Affairs and QMS.

Your experience and qualifications

Academic Degree/PG and thinking level with a chemical/pharmaceutical background.
6+ years of experience in CMC Regulatory Affairs; Europe and International Market preferred.
Knowledge on EU registration procedures and pharmaceutical regulations.
Good communication skills (written and oral).
Interest and capability to work with different software, including Document Management Systems.
Accurate, able to prioritize and work according to agreed timelines.
Working independently with a moderate level of guidance and direction.
Solve complex problems using existing solutions and support.
Identify & implement process improvements. Team player

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