Rusan Pharma Hiring Regulatory Affairs

Rusan Pharma Hiring – Regulatory Affairs | Pharma | Mumbai

Rusan Pharma is looking for an experienced Regulatory Affairs professional with hands-on expertise in DCGI/CDSCO submissions and pharmaceutical formulation.

The position requires a minimum of 4+ years of experience, with formulation experience being mandatory.

Candidates with B.Pharm or M.Pharm qualifications and expertise in regulatory submissions, CTD/eCTD dossiers, and regulatory documentation can apply.

The company is looking for candidates who can join immediately in Kandivali West, Charkop, Mumbai.

Job Details

Regulatory Affairs – Pharma

• Company: Rusan Pharma
• Department: Regulatory Affairs
• Location: Kandivali West, Charkop, Mumbai
• Experience: 4+ years – Mandatory
• Formulation Experience: Mandatory
• Qualification: B.Pharm / M.Pharm
• Joining: Immediate joiners preferred

Regulatory Affairs Responsibilities

DCGI/CDSCO & SUGAM Submissions

• Handle DCGI/CDSCO submissions.
• Work on submissions through the SUGAM Portal.
• Prepare and manage regulatory applications related to pharmaceutical products.

Form CT Applications

Hands-on experience with Form CT applications for

• Clinical Trials
• BA/BE
• Import License
• New Drug Permission

CTD/eCTD & Regulatory Documentation

• CTD/eCTD dossier compilation.
• Regulatory documentation.
• Query response and deficiency management.
• Labelling review.
• PI review.

Cross-Functional Coordination

Coordinate with

• R&D
• Quality Assurance (QA)
• Quality Control (QC)
• Manufacturing
• Clinical teams

Eligibility & Qualifications

• B.Pharm
• M.Pharm
• 4+ years of Regulatory Affairs experience – Mandatory
• Formulation experience – Mandatory

Key Expertise

Candidates should have hands-on expertise in

• DCGI/CDSCO submissions
• SUGAM Portal submissions
• Form CT applications
• Clinical Trial submissions
• BA/BE applications
• Import License applications
• New Drug Permission
• CTD/eCTD dossier compilation
• Query response
• Deficiency management
• Regulatory documentation
• Labelling review
• PI review
• Cross-functional coordination

Eligible Qualification Courses

B.Pharm | M.Pharm

Location

Kandivali West (Charkop), Mumbai, Maharashtra

How to Apply

Interested candidates who meet the mandatory experience and formulation requirements can share their updated CV at:

Email: fehmida.shaikh@rusanpharma.com

Immediate joiners are preferred.

Job Summary

Category

Details

Company

Rusan Pharma

Vacancies

Regulatory Affairs – Pharma

Required Education

B.Pharm, M.Pharm

Experience

4+ years; formulation experience mandatory

Tagged as: Clinical Research, Clinical Trials, Documentation, eCTD, Formulation, Qualification, Regulatory Submissions