Company Description Nabros Pharma Pvt. Ltd., established in 1983 and headquartered in Ahmedabad, Gujarat, India, is a globally recognized pharmaceutical company with a strong focus on research, advanced formulation, manufacturing, and strategic marketing. The company operates state-of-the-art manufacturing facilities that comply with cGMP standards and are supported by rigorous quality assurance and SOP-driven processes.

Its WHO-GMP certified units are designed using Quality by Design (QbD) principles and are regularly audited by international regulatory bodies, reflecting a robust commitment to global quality norms.

Certifications such as ISO 9001:2015 further highlight the company’s adherence to international standards. With a diverse portfolio spanning pharmaceuticals, nutraceuticals, and essential phospholipids, Nabros Pharma supports better healthcare and quality of life worldwide through an extensive global distribution network.

Role Description The International Regulatory Affairs Manager is responsible for overseeing regulatory strategies and submissions for global markets, ensuring that Nabros Pharma’s products comply with international regulatory requirements. This full-time, hybrid role is based in Ahmedabad, with the flexibility for some work from home. Day-to-day responsibilities include preparing, reviewing, and coordinating dossiers and technical documents for submissions to regulatory authorities; managing responses to regulatory queries; and maintaining up-to-date knowledge of global regulations and guidelines.

The role involves close collaboration with R&D;, quality assurance, manufacturing,



and marketing teams to ensure product development and lifecycle management align with regulatory expectations. The manager also supports audits and inspections, drives continuous improvement in regulatory processes, and contributes to expanding market approvals and maintaining existing registrations.

Qualifications

- Strong expertise in international regulatory affairs, including preparation and management of CTDs, dossiers, and product registration documents for multiple global regions.
- Solid understanding of cGMP, WHO-GMP, ICH guidelines, and other international regulatory frameworks, with experience supporting regulatory inspections and audits.
- Ability to collaborate effectively with cross-functional teams such as R&D;, QA, QC, production, and marketing to align regulatory requirements with business objectives.
- Excellent skills in documentation, technical writing, data review, and attention to detail for accurate, compliant submissions.
- Strong analytical, problem-solving, and decision-making abilities to address regulatory challenges and interpret evolving guidelines.
- Effective communication and stakeholder management skills, including clear interaction with regulatory agencies, external partners, and internal leadership.
- Proficiency with regulatory information systems, document management tools, and standard office software for tracking submissions and maintaining records.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field; prior experience in regulatory affairs within the pharmaceutical or nutraceutical industry is highly desirable.
- Demonstrated

📌 International Regulatory Affairs Manager (Ahmedabad)
🏢 NABROS PHARMA
📍 Ahmedabad