Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end to end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe, and Asia.
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This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs, and Finished dosage forms. We also offer specialized services like the development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Position: Regulatory Affairs, Executive
Location: Mumbai, Maharashtra, India
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 Stake Holders:
Internal: Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management, Labeling, Packaging Development
External: Country Distributors, Health Authority (HA), external partners
- 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 labeling 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.
Desired Skills & Experience:
- Knowledge of Document Control procedures and Good Manufacturing Practice (GMP) is required
- Quality review for Standard Operating Procedures, technical documents necessary.
- Knowledge of global regulatory filings required.
- Must effectively multi-task, establish priorities, and work in a fast-paced environment.
- Experience preparing regulatory submissions.
- Ability to interpret and regulatory standards and guidance.
- Demonstrated understanding of related fields (i.e. pharmaceutical manufacturing, quality assurance, quality control, pharmacovigilance, labeling, and pharmaceutical packaging)
- Effective interpersonal skills and problem-solving techniques.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Strong oral, written communication, and listening skills.
- Experience in reviewing scientific information and technical documents.
- Regulatory affairs experience with the US market is a plus.
Qualification: B Pharm / M Pharm / M Sc. degree in a related field.
Experience: 2 to 5 years’ experience in regulatory affairs preferred, supporting LATAM/ US region and/or ROW region
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