Cubit Lifesciences LLP is hiring experienced professionals for Regulatory Affairs (RA) at its Ahmedabad, Gujarat location. Candidates with 3 to 8 years of experience in regulatory affairs for oral solid dosage (OSD) or injectables, particularly across emerging markets, are invited to attend the walk-in interview.
Job Details
| Particulars | Details |
|---|---|
| Company | Cubit Lifesciences LLP |
| Job Role | Regulatory Affairs (RA) |
| Experience | 3–8 Years |
| Qualifications | B.Pharma / M.Pharma |
| Dosage Forms | OSD / Injectables |
| Location | Prahlad Nagar, Ahmedabad, Gujarat |
| Interview Type | Walk-in Interview |
Position: Regulatory Affairs (RA)
The selected candidates will handle regulatory dossier preparation and review, product registration and re-registration, regulatory submissions, variations, and product lifecycle management.
Job Responsibilities
- Plan, prepare, and review registration and re-registration dossiers in CTD, eCTD, ACTD, and country-specific formats.
- Compile and submit regulatory queries and variations.
- Review regulatory documents and product artworks.
- Review change controls and deviations.
- Conduct gap analysis and prepare regulatory strategies for new product filings.
- Maintain product lifecycle activities.
- Coordinate with internal and external stakeholders regarding submission documents and payments.
Eligibility and Qualifications
Candidates applying for the Regulatory Affairs position must meet the following requirements:
- Educational Qualification: B.Pharma or M.Pharma.
- Experience: 3 to 8 years in Regulatory Affairs.
- Relevant Experience: Regulatory Affairs experience involving oral solid dosage (OSD) forms or injectables.
- Market Experience: Candidates who have worked in Africa, LATAM, CIS, Asia, MENA, or other emerging markets are invited to attend the walk-in interview.
Required Skills and Expertise
Candidates should have relevant experience in:
- CTD, eCTD, ACTD, and country-specific regulatory dossiers.
- Product registration and re-registration.
- Regulatory query and variation submissions.
- Regulatory document and artwork review.
- Change control and deviation review.
- Gap analysis and regulatory strategy preparation.
- Product lifecycle management.
- Coordination with internal and external stakeholders.
Walk-in Interview and Application Details
Eligible candidates can attend the walk-in interview at Cubit Lifesciences LLP in Ahmedabad or contact the company using the details below.
Company: Cubit Lifesciences LLP
Venue:
Cubit Lifesciences LLP
Pinnacle Business Park, 4th Floor, B-406/407, Corporate Road, Prahlad Nagar, Ahmedabad, Gujarat – 380015.
Email: tapas@cubitgroup.in
