Job Description
1. Trainee Intern – Regulatory Affairs (job Code : JP8)
Key Responsibilities:
- Coordinate with internal teams for document review and submissions.
- Ensure compliance with internal and client document management SOPs.
- Maintain proper records and assist in regulatory processes.
Candidate Profile:
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- Strong interpersonal and communication skills.
- Basic computer proficiency.
- Eagerness to learn and adapt in a fast-paced environment.
- Ability to work under tight deadlines.
2. Senior Executive – Regulatory Affairs (job Code: JP6)
Key Responsibilities:
- Perform high-quality CMC review of technical documents (CTD Modules, SmPCs, PIs, PILs, Labeling).
- Attend pre-submission meetings with Health Authorities (HAs) and prepare post-meeting reports.
- Assist in dossier preparation for emerging markets.
- Conduct gap analysis for Non-CTD/CTD/ACTD dossiers.
- Manage HA deficiencies/supplements and coordinate responses.
- Ensure data security compliance and proper documentation.
- Collaborate with internal/external teams for regulatory submissions & translations.
- Provide regulatory intelligence and market insights.
Candidate Profile:
- Strong project management & communication skills.
- Knowledge of emerging market regulations (preferred).
- Ability to work under pressure with tight deadlines.
- Uttarakhand-based candidates will be prioritized.
About the Company
We are a leading organization in the pharmaceutical regulatory affairs domain, specializing in global submissions, compliance, and dossier management. Our team works closely with emerging markets, ensuring seamless regulatory approvals for clients.
At PharmaBharat.com, we connect top talent with leading pharmaceutical opportunities, fostering growth and innovation in the industry.
How to Apply
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