Regulatory Affairs Manager

We’re Hiring: Regulatory Affairs Manager / Senior Regulatory Affairs Executive

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Are you a regulatory professional who thrives at the intersection of science, strategy, and execution? We’re looking for a driven Regulatory Affairs leader to help shape and expand pharmaceutical products across India and global markets. This role is ideal for someone with a strong regulatory foundation, commercial awareness, and an entrepreneurial mindset.

🔍What You’ll Do

As a key member of our regulatory team, you will play a critical role in product development, registration, and lifecycle management across multiple markets.

Regulatory Submissions & Compliance

• Prepare, review, and submit regulatory dossiers (CTD/eCTD/ACTD) for product registration, variations, and renewals to FDA and other global health authorities.
• Ensure accuracy and completeness of CMC, non-clinical, and clinical documentation in line with market-specific requirements.
• Review and prepare Non-Clinical & Clinical Data, including RMPs, PSURs, and post-approval documentation.
• Maintain full compliance with national and international regulatory guidelines, timelines, and best practices.

Cross-Functional & External Coordination

• Collaborate closely with R&D, QA, QC, Manufacturing, and Marketing teams to gather, verify, and align technical documentation.
• Coordinate with API manufacturers for DMFs, COAs, and regulatory queries.
• Liaise with BE/CDP centers to support bioequivalence and clinical requirements.
• Provide regulatory support during GMP audits, inspections, and site compliance activities.

Strategy, Monitoring & Market Support

• Develop and execute regulatory strategies for new products and market entry.
• Support product launches with timely regulatory input.
• Monitor evolving global regulatory guidelines and proactively communicate changes to stakeholders.
• Maintain accurate records of submissions, approvals, and correspondence with health authorities.
• Support pharmacovigilance and post-marketing surveillance activities as required.

What We’re Looking For

Qualifications

✔ Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field

✔ 3–5 years of experience in Regulatory Affairs and/or pharmaceutical contract manufacturing tie-ups

✔ Strong understanding of the Indian pharmaceutical market and licensing processes

✔ Proven negotiation, communication, and relationship management skills

✔ Entrepreneurial mindset with the ability to excel in a fast-paced environment

Technical Skills & Knowledge

• Solid understanding of global regulatory frameworks (USFDA, EMA, MHRA, TGA, Health Canada, CDSCO – India, ASEAN, WHO)
• Hands-on experience with DMF, ANDA, NDA, MAA, CTD/eCTD submissions
• Knowledge of variations, renewals, and post-approval changes
• Familiarity with ICH, GxP, GMP, and pharmacovigilance regulations
• Strong scientific writing and documentation skills
• Proficiency in MS Office and regulatory submission tools/software

Why Join Us?

• Work on high-impact pharmaceutical products with global exposure
• Be part of a growing, agile organization that values initiative and expertise
• Collaborate with experienced cross-functional and international teams
• Opportunity to shape regulatory strategy and influence market expansion

Ready to make an impact?

Apply now and be part of a team driving quality, compliance, and innovation in pharmaceuticals.

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