A great opportunity is open for experienced Regulatory Affairs professionals specializing in ROW markets (Rest of World). This role is ideal for candidates who have strong expertise in dossier preparation and regulatory submissions for parenteral products.
The company is looking for skilled professionals who can independently manage end-to-end regulatory processes and contribute effectively from day one. Immediate joiners will be given preference.
Job Overview
- Role: Regulatory Affairs – ROW Market (Parenterals)
- Location: Hyderabad, India
- Experience: 4–7 Years
- Industry: Pharmaceutical / Healthcare
- Joining: Immediate joiners preferred
Key Responsibilities
- Prepare and review regulatory dossiers for ROW markets
- Handle end-to-end submission processes across multiple countries
- Develop and compile CTD Modules 2–5 (mandatory requirement)
- Ensure compliance with country-specific regulatory guidelines
- Coordinate with cross-functional teams for documentation and submissions
- Track submission timelines and follow up with health authorities
- Maintain regulatory records and documentation accuracy
Required Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- 4–7 years of experience in Regulatory Affairs (ROW markets)
- Strong expertise in CTD Modules 2–5 preparation
- Hands-on experience with parenteral products (essential)
- Ability to manage complete regulatory submission lifecycle
- Candidates with only publishing experience will not be considered
Salary & Benefits
- Estimated Salary: ₹6,00,000 – ₹12,00,000 per annum (based on experience)
- Opportunity to work on global regulatory markets
- Career growth in a specialized domain
- Exposure to international submission standards
- Professional and collaborative work environment
How to Apply
Interested candidates can share their updated CV at:
Make sure to apply early, as immediate joiners are highly preferred.