Drug Regulatory Affairs

This role is for one of the Weekday's clients

Min Experience: 3 years

Location: Haryana, Punjab

JobType: full-time

We are seeking a detail-oriented and experienced Drug Regulatory Affairs professional to manage and support regulatory submissions, approvals, and lifecycle maintenance for pharmaceutical products. The role will be responsible for ensuring compliance with national and international regulatory requirements across product development, registration, and post-approval stages. The ideal candidate will have hands-on experience working with regulatory authorities and cross-functional teams to ensure timely approvals and sustained compliance.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for pharmaceuticals, including CTD / eCTD submissions for new drug applications, variations, renewals, and amendments.
• Manage regulatory submissions to authorities such as CDSCO, DCGI, US FDA, EMA, MHRA, or other global health authorities, as applicable.
• Ensure compliance with applicable regulatory guidelines, standards, and timelines throughout the product lifecycle.
• Coordinate with internal stakeholders including R&D, QA, QC, Manufacturing, Clinical, and Supply Chain teams to gather and validate regulatory documentation.
• Track and respond to regulatory queries, deficiency letters, and follow-up communications from health authorities.
• Maintain up-to-date knowledge of changing regulatory requirements, guidelines, and policies, and assess their impact on existing and pipeline products.
• Support regulatory strategy development for new product registrations, line extensions, and market expansions.
• Manage post-approval activities including labeling changes, variations, renewals, site changes, and pharmacovigilance-related submissions.
• Maintain regulatory databases, submission trackers, and documentation in compliance with internal SOPs and audit requirements.
• Assist during regulatory inspections, audits, and internal compliance reviews.

Required Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 3–7 years of hands-on experience in Drug Regulatory Affairs within the pharmaceutical or life sciences industry.
• Strong understanding of global regulatory frameworks, submission processes, and documentation standards.
• Experience in dossier preparation, review, and submission for regulated markets.
• Familiarity with ICH, WHO, GMP, GxP, and regulatory guidelines.

Skills & Competencies

• Strong attention to detail and excellent documentation skills.
• Ability to manage multiple submissions and priorities under tight timelines.
• Effective communication and coordination skills for cross-functional collaboration.
• Analytical mindset with strong problem-solving abilities.
• Proficiency in MS Office and regulatory submission tools/software.