Nabros Pharma
Website:
nabros.in
Job details:
Regulatory Affairs Manager / Senior Manager – International Regulatory Affairs
Company: Nabros Pharma Pvt. Ltd.
Location: Ahmedabad, Gujarat, India
Work Mode: Full-time, On-site
Experience: 8–12 years
Education: B.Pharm / M.Pharm / Pharm.D / Pharmaceutical Sciences / Life Sciences
Function: International Regulatory Affairs
Geographic Focus: Africa & LATAM
About Nabros Pharma Pvt. Ltd.
Nabros Pharma Pvt. Ltd., established in 1983 and headquartered in Ahmedabad, Gujarat, India, is a pharmaceutical company engaged in research, development, manufacturing and international business.
Nabros operates cGMP-compliant and WHO-GMP certified manufacturing facilities and has a diversified portfolio covering pharmaceutical formulations, injectables/parenterals, oral solids, oral liquids, semi-solids/topical products, nutraceuticals, food supplements, essential phospholipids and specialty healthcare products.
With an established international presence and exports to multiple global markets, Nabros is strengthening its International Regulatory Affairs function to support new market entry, product registrations, lifecycle management, regulatory compliance and business expansion across Africa, LATAM and other emerging markets.
Position Overview
We are seeking an experienced Regulatory Affairs Manager / Senior Manager – International Regulatory Affairs to lead regulatory activities for pharmaceutical products across international markets, with primary focus on Africa and LATAM.
The ideal candidate will combine strong technical regulatory expertise with a techno-commercial mindset, enabling the organization to evaluate registration feasibility, develop market-entry strategies, manage dossiers, obtain approvals, maintain registered portfolios and support commercial launch timelines.
The candidate should have hands-on experience in CTD/eCTD submissions, pharmaceutical product registrations, injectable/parenteral products, lifecycle management, Health Authority interactions and regulatory deficiency management.
Key Responsibilities1. Regulatory Strategy & Market Access
- Develop regulatory strategies for new product registrations and market expansion.
- Conduct regulatory feasibility assessments for new countries and products.
- Evaluate country-specific registration pathways, documentation and timelines.
- Identify regulatory risks and opportunities and recommend mitigation strategies.
- Support product selection, business cases and commercial launch planning.
- Provide regulatory intelligence on evolving international requirements.
- Partner with Business Development, QA, R&D, Manufacturing, Supply Chain, Medical and Pharmacovigilance teams.
2. Dossier & Submission Management
- Manage end-to-end regulatory submissions for new registrations, renewals, variations, transfers, amendments and post-approval changes.
- Prepare, compile and review CTD/eCTD dossiers and country-specific Module 1 requirements.
- Coordinate technical documentation from R&D, QA, QC, Manufacturing, Clinical and other departments.
- Ensure submissions are complete, accurate and compliant with applicable regulations.
- Track submission milestones and ensure timely completion against business launch timelines.
3. Injectable / Parenteral Products
Hands-on experience with sterile and parenteral product registrations is strongly preferred and will be a key selection criterion.
4. Health Authority & Regulatory Partner Management
- Lead communication with Health Authorities, Ministries of Health, regulatory agencies, local agents, consultants and distributors.
- Manage regulatory queries, deficiencies, clarification requests and commitments.
- Prepare and coordinate high-quality responses within defined timelines.
- Monitor approval timelines and proactively address bottlenecks.
- Support GMP/site approvals, inspections and regulatory audits.
- Build effective relationships with regulatory stakeholders.
5. Product Lifecycle & Compliance
- Ensure continuous compliance of the registered product portfolio.
- Manage renewals, variations, technical amendments and post-approval commitments.
- Monitor registration validity and renewal deadlines.
- Coordinate changes relating to formulation, manufacturing site, API/source, packaging, specifications, processes and artwork.
- Maintain regulatory documentation and ensure registration data remains current.
- Prevent regulatory delays that could impact product supply or market availability.
6. Regulatory Intelligence & Digitalization
- Monitor changes in international and country-specific regulations.
- Assess regulatory impact on existing and pipeline products.
- Develop and maintain regulatory trackers, dashboards and databases.
- Ensure accurate, real-time visibility of submissions, approvals, renewals, variations and commitments.
7. Business & Commercial Support
Act as a regulatory business partner to International Business Development.
Provide regulatory input on:
- Product selection
- Market feasibility
- Registration pathway
- Dossier requirements
- Stability requirements
- BE/clinical requirements
- GMP/site approval
- Registration timelines
- Regulatory risks
- Launch readiness
- Post-approval requirements
The candidate must understand how regulatory strategy directly affects business opportunity, product launch, revenue and market availability.
8. Team Leadership
For Senior Manager-level candidates:
- Manage and mentor junior RA professionals.
- Allocate regulatory projects and monitor performance.
- Review dossiers and regulatory correspondence.
- Establish SOPs, workflows and tracking mechanisms.
- Train team members on international regulatory requirements.
- Drive accountability for submission and approval timelines.
Geographic Experience:
Africa & LatamExperience in GCC/MENA, CIS/EAEU or Southeast Asia will be an additional advantage.
Mandatory Qualifications & Skills
- B.Pharm/M.Pharm/Pharm.D/Pharmaceutical Sciences/Life Sciences or related degree.
- 8–12 years of relevant pharmaceutical Regulatory Affairs experience.
- Strong international regulatory experience.
- Proven experience in product registrations and lifecycle management.
- Hands-on CTD/eCTD knowledge.
- Experience with regulatory queries and deficiency responses.
- Strong Health Authority interaction experience.
- Hands-on experience with injectable/parenteral product registrations.
- Understanding of GMP and manufacturing-site approval requirements.
- Strong technical writing and documentation skills.
- Excellent project management and cross-functional coordination skills.
- Strong analytical, problem-solving and organizational abilities.
- Excellent English communication skills.
- Spanish and/or Portuguese will be an added advantage.
Preferred Candidate Profile
The ideal candidate should be:
Pharma-qualified + International RA professional + CTD/eCTD expert + Injectable registration experience + Africa/LATAM exposure + Health Authority experience + Lifecycle management + GMP/site approval knowledge + Strong techno-commercial understanding + Leadership capability.
Candidate Screening Criteria
Freshers are strictly not eligible.
Candidates with only Indian domestic regulatory experience will not be preferred.
Candidates should have actual hands-on experience in international pharmaceutical registrations rather than purely administrative/document coordination roles.
Experience in multiple African or LATAM countries, injectable registrations and direct Health Authority interactions will be strongly preferred.
Local Ahmedabad/Gujarat candidates are highly preferred. Candidates willing to relocate permanently to Ahmedabad may also be considered.
Key Performance Indicators
Performance will be measured through:
- Timely dossier submissions
- Number and quality of regulatory approvals
- Submission-to-approval timelines
- Regulatory query response timelines
- Renewal and variation completion
- Closure of regulatory commitments
- Registration expiry prevention
- Accuracy of regulatory databases
- Regulatory support for new market launches
- Reduction of regulatory delays
- Cross-functional project delivery
Interview Assessment
Shortlisted candidates may be evaluated through a practical regulatory case study.
Example: Registration of a generic injectable product in Kenya, Nigeria, Colombia and Peru.
The candidate may be asked to explain:
- Registration pathway
- Required dossier
- CTD/eCTD requirements
- Technical documentation
- Stability/BE requirements
- GMP/site approval requirements
- Regulatory risks
- Expected timelines
- Deficiency-response strategy
- Launch-readiness plan
Candidates should demonstrate practical knowledge rather than only theoretical regulatory understanding.
Red Flags
Candidates may not be suitable if they:
- Cannot identify Health Authorities they have worked with.
- Claim Africa/LATAM experience without specific country exposure.
- Cannot explain CTD modules.
- Have never independently managed regulatory queries.
- Have no injectable/parenteral registration experience.
- Have only performed document coordination.
- Cannot explain variations and renewals.
- Cannot provide examples of actual regulatory approvals.
- Have no understanding of commercial launch timelines.
- Have no knowledge of GMP/site approvals.
Why Join Nabros?
Nabros offers an opportunity to work in an international pharmaceutical environment where Regulatory Affairs is closely integrated with Business Development, Product Selection, Manufacturing, Quality and Global Market Expansion.
The successful candidate will contribute directly to international product registrations, new market entry, portfolio expansion and regulatory strategy across high-growth emerging markets.
Apply if you have strong hands-on international pharmaceutical regulatory experience and are ready to take ownership of Africa & LATAM regulatory activities.
Position Summary
Location: Ahmedabad, Gujarat
Employment: Full-time, On-site
Experience: 8–12 years
Education: B.Pharm/M.Pharm/Pharm.D/related discipline
Freshers: Not eligible
Local candidates: Highly preferred
International/Africa/LATAM RA experience: Strongly preferred
📞 Facilitated By
👤 Mr. Hiren Trivedi
🌍 Executive Director
📱 (+91) 97272 12507 || (+91) 72288 17518
📧 hiren.trivedi@nabros.in
🌐 www.nabros.in
Click on Apply to know more.