Piramal Regulatory Affairs Pharma Jobs – Apply Online
The Piramal Critical Care is currently hiring for the position of Executive Regulatory Affairs. If you have experience in the pharmaceutical industry and regulatory affairs, this could be the right opportunity for you. Located in Mumbai, Maharashtra, India, the role offers the chance to work with a leading company in the field. Read on to find out more about the position and how to apply.
Job Description
Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla, Mumbai
Travel: Low
Job Overview
The role of Executive Regulatory Affairs is responsible for the assigned portfolio of Piramal Critical Care products in applicable region(s). Reporting to the Manager, Regulatory Affairs, the executive will work closely with the regulatory management to ensure that all regulatory strategies are executed and submissions are sent to relevant Health Authorities within the required timeframes. The executive will also represent the department on cross-functional teams to ensure compliance with regulatory requirements and meet submission deadlines.
Key Stakeholders: Internal
- Country manager
- Plant
- QA
- Artwork department
- Supply Chain
- PV
Key Stakeholders: External
- Health Authorities
- Distributors
Reporting Structure
The role reports to the Manager, Regulatory Affairs and does not have any direct reports.
Experience
- 3 to 6 years’ experience in a pharmaceutical environment
- 2 to 3 years of regulatory affairs experience preferred, supporting ROW/LATAM region
- Well versed with ICH and other international guidance’s, laws, and regulations, specifically about Rest of the World/LATAM regions
- Good Manufacturing Practice (GMP) knowledge required
Key Role & Responsibilities
- Work closely with RA management to ensure regulatory strategies are executed and submissions are sent to relevant Health Authorities within required timeframes
- Along with direct management supervision represent regulatory affairs on internal/external cross functional teams to ensure projects remain on track
- 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- if required, 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/ LATAM regions.
- Responsible to update himself/herself with the relevant current National and ICH guidelines’ along with global regulatory requirements.
Key Competencies
- Excellent communication skills using both spoken and written English
- Proficient in the use of Microsoft Office, especially Word and Excel
- Ready to take challenges in work and manage priorities and deadlines
- Able to work independently on multiple projects/tasks simultaneously
- Excellent coordination and collaboration with other teams and departments globally
- Good attention to detail and able to review documents and provide critical assessment of information and data
- Excellent relevant technical knowledge from a scientific background, ideally with the pharmaceutical or allied industry
Qualifications
B Pharm / M Pharm / M Sc. degree in a related field.
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