Piramal Regulatory Affairs Executive Vacancy – Apply Online
Piramal Pharma Vacancy Piramal Pharma. Piramal Ltd invites postgraduate and undergraduate Pharma candidates for the post of Regulatory Affairs Executive. Interested and eligible candidates may apply online. Check out all the details on Rasayanika.com
Job Title: Regulatory Affairs Executive I
Business Unit: Critical Care
Equivalent Job Titles: IN – Regulatory Affairs Executive
Location: IN
Band/Grade: 1B
Department; Group: Regulatory Affairs
Degree of Travel required to: Low
Purpose of Job
The role is responsible for the assigned portfolio of Piramal Critical Care products in the 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 stakeholders
External
Internal
Country Distributors, Health Authority (HA), external partners
Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management, Labeling, Packaging Development
Essential Qualifications
- 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.
Essential Experience
Knowledge of
Document Control procedures.Quality review for Standard Operating Procedures, technical documents necessary.
Knowledge of global regulatory filings required.
Job Conditions
This position is based in the Kurla Corporate office.
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 stakeholders within predefined timelines.
- Assist team with labelling updates as required to ensure timelines remain on target.
Responsible for requests for complementary 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 assists in change control 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 guidelines along with global regulatory requirements.
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