Senior Manager -Regulatory Affairs-Biologics

Drlogy; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Drlogy is seeking a Senior Manager for Regulatory Affairs specializing in biologics. This role involves leading global regulatory strategies and ensuring compliance for biopharmaceutical products. The ideal candidate will prepare and manage regulatory submissions, coordinate with cross-functional teams, and monitor evolving regulations.

The successful applicant will drive process improvements within regulatory affairs and mentor teams on compliance best practices while engaging with health authorities.

Qualifications

• Experienced in leading regulatory affairs activities for biologics.
• Proficient in developing global regulatory strategies aligned with product goals.
• Skilled in managing regulatory documentation and submissions.

Responsibilities

• Lead regulatory affairs activities for biologics products.
• Develop and execute global regulatory strategies.
• Prepare and submit regulatory dossiers like IND, BLA, and CTD.

Skills

Leading global regulatory strategies

Regulatory submissions

Compliance activities

Cross-functional collaboration

Lifecycle management

Job description

Senior Manager - Regulatory Affairs - Biologics

Experienced Senior Manager – Regulatory Affairs – Biologics responsible for leading global regulatory strategies, biologics submissions, and compliance activities for biopharmaceutical products. Skilled in managing regulatory dossiers, health authority interactions, lifecycle management, and compliance with international biologics regulations. Adept at collaborating with cross-functional teams to support product development, approvals, post-approval changes, and regulatory risk management while ensuring timely submissions and sustained regulatory compliance.

• Lead regulatory affairs activities for biologics and biopharmaceutical product portfolios.
• Develop and execute global regulatory strategies aligned with business and product development goals.
• Prepare, review, and submit regulatory dossiers including IND, BLA, CTD, and related submissions.
• Ensure compliance with international regulatory guidelines and biologics-specific requirements.
• Coordinate with R&D, clinical, manufacturing, quality, and analytical teams for regulatory documentation.
• Manage lifecycle maintenance activities including variations, renewals, supplements, and change controls.
• Support interactions and communications with health authorities and regulatory agencies.
• Review technical documents related to biologics manufacturing, characterization, stability, and quality systems.
• Monitor evolving global biologics regulations and assess impact on ongoing projects.
• Lead responses to regulatory queries, deficiency letters, and inspection observations.
• Support regulatory intelligence activities and provide strategic guidance to internal stakeholders.
• Participate in audits, inspections, and compliance assessments related to biologics products.
• Ensure accurate maintenance of regulatory databases, submission trackers, and documentation records.
• Drive process improvement initiatives to enhance regulatory efficiency and submission quality.
• Mentor and guide regulatory affairs teams on biologics regulations, compliance standards, and best practices.