Executive Regulatory Affairs @ Piramal Enterprises Ltd , BA/BS/B Pharm degree
in a science or related field Apply Now
The role is responsible for the assigned
portfolio of Piramal Critical Care products in applicable region(s). With
oversight from Regulatory management the Regulatory Affairs Executive will
represent the department on cross-functional teams to ensure PCC and its
partners are aware of all regulatory requirements and meet pre-defined
submission timelines.
Key Roles/Responsibilities:
- Work
closely with RA management to ensure regulatory strategies are executed
and submissions are sent to Health Authorities within required timeframes
- Along
with direct management supervision represent regulatory affairs on
internal/external cross functional teams to ensure projects remain on time
- Compile
and submit appropriate supplemental filings/variations/renewals to support
drug product manufacturing, product life cycles etc.
- Responsible
for addressing queries received from regulatory agencies, internal and
external stake holders within predefined timelines.
- Assist
team with labeling updates as required to ensure timelines remain on
target.
- Responsible
for requests for complimentary elements (CPPs, declarations, License
applications etc.)
- Responsible
for overall document management and regulatory data consolidation for all
products into information software
- Along
with direct management supervision assist in change controls for
assessment, completing assigned action for RA.
- Responsible
for uploading the submission copies and other updated quality data in
sharepoint.
- Responsible
for approval of export orders for ROW regions.
- Responsible
to update himself/herself with the relevant current National and ICH
guideline’s along with global regulatory requirements.
Essential
Qualifications
BA/BS/B Pharm degree in a science or related field.
Good Manufacturing Practice (GMP) knowledge required.
2 to 5 years’ experience in a pharmaceutical environment with 1 to
2 years of regulatory affairs experience preferred supporting ROW region.
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Piramal Enterprises Limited