Rusan Pharma Hiring For Regulatory Affairs

Rusan Pharma is hiring for the position of Executive / Senior Executive – DCGI Submissions in the Regulatory Affairs department at Charkop, Kandivali West, Mumbai. Candidates with 4+ years of experience and hands-on expertise in DCGI/CDSCO submissions and Indian regulatory requirements are invited to apply.

Job Details

Positions Available

• Executive – DCGI Submissions
• Senior Executive – DCGI Submissions

Key Responsibilities

The role involves regulatory submissions, dossier preparation, documentation, and coordination with cross-functional teams.

Key areas of work include:

• Preparing and submitting applications through the CDSCO SUGAM Portal.
• Handling Form CT applications for clinical trials, BA/BE studies, import licences, and new drug permissions.
• Compiling CTD/eCTD regulatory dossiers.
• Managing regulatory queries and deficiencies.
• Reviewing regulatory documentation, labelling, and package inserts (PI).
• Coordinating with R&D, QA, QC, Manufacturing, and Clinical teams.
• Working with Indian regulatory requirements under the Drugs and Cosmetics Act and Rules.

Eligibility and Qualifications

Candidates should have:

• 4+ years of professional experience.
• Hands-on experience with DCGI/CDSCO submissions.
• Knowledge of Indian regulatory requirements.

Required Skills

• CDSCO SUGAM Portal submissions
• Form CT applications
• Clinical trial and BA/BE regulatory submissions
• Import licence and new drug permission applications
• CTD/eCTD dossier compilation
• Regulatory query responses and deficiency management
• Regulatory documentation and labelling review
• Package insert (PI) review
• Knowledge of the Drugs and Cosmetics Act and Rules
• Cross-functional coordination with R&D, QA, QC, Manufacturing, and Clinical teams

How to Apply

Interested candidates can share their CV via email for the Executive / Senior Executive – DCGI Submissions position at Rusan Pharma.

Email: fehmida.shaikh@rusanpharma.com

Location: Charkop, Kandivali West, Mumbai