Senior Associate – Regulatory Affairs (EU-OTC)

India·Bangaloresenior

OtherRegulatory Affairs

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Requirements Summary

Minimum B.S. Chemistry, Biology, or related fields Minimum of 4 ~ 5 years of experience w

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OtherRegulatory Affairs

Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc.
Support for the registration of OTC drugs in EU countries.
Support regional RA team to compile submission packages.
Prepare cover letter, application form and relevant Module 1 documents for variations.
Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA.
Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing.
Work with regional regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.
Regulatory review of submission documents for compliance.
Work with cross-functional teams or LRA’s for submission documents and verification of packages.
Updating relevant submission tracker i.e. J tracker, HAQ tracker, PSMF tracker etc.

Review and edit the consolidated CFI independently and with applying critical thinking and common sense
Make sure that all the regulatory actions provided in the consolidated CFI fit for purpose (i.e. meet requirements of GVP module VII.B.5.1 to 4) and are written in such a way that it can be directly copied into the aggregate report
Challenge LOC if their contribution is not appropriate
Review the regulatory contribution in the draft and final aggregate report based on the outcome of the consolidated CFI
Submit the PSUSA and follow until completion
Submit the post PSUSA variations

~1 min read

Minimum B.S. Chemistry, Biology, or related fields
Minimum of 4 ~ 5 years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations.