Manager Regulatory Affairs (PSS08004)

About the Company

A leading multinational organization in the pharmaceutical sector, committed to ensuring regulatory compliance and timely market access for its products. The company operates across global and local markets, emphasizing quality, safety, and adherence to evolving health authority standards.

Position Overview

The Regulatory Affairs professional will ensure that all regulatory updates and actions are executed accurately and on schedule for assigned products and therapeutic areas. The role is pivotal in maintaining compliance, securing timely approvals, and supporting uninterrupted product availability. This position is based in Delhi and collaborates closely with both local and global teams.

Key Responsibilities

• Ensure all regulatory updates are communicated promptly to local and global teams.
• Execute operational Regulatory Affairs tasks in a timely and compliant manner.
• Develop and implement strategies that comply with applicable regulations and standards.
• Liaise with the Health Authority to secure earliest possible submissions and registrations.
• Follow up on regulatory approvals in line with the registration plan.
• Coordinate with the Health Authority to enable timely implementation of proposed CMC changes per global timelines.
• Manage renewals to ensure uninterrupted product availability in the country.
• Oversee amendments and updates to maintain study continuity and ensure timely notifications of notifiable changes.
• Track and follow up on submitted applications with the Health Authority.
• Maintain the RIN database by entering and assessing the impact of each relevant update in RINTOOL.

Required Experience & Qualifications

• Education: Bachelor’s degree in pharmacy or similar medical education.
• Experience: Pharmaceutical industry experience with a regulatory focus in a multinational environment.
• Leadership: Direct interaction and liaison experience with Regulatory Authorities and Health Authorities.
• Technical Expertise: Solid understanding of the D&C Act and Rules, regulatory submission processes, and RINTOOL database management.
• Soft Skills: Strong analytical ability, attention to detail, effective communication, and negotiation skills.

Why Consider this Opportunity?

• Play a critical role in ensuring regulatory compliance and product availability in a key market.
• Engage directly with Health Authorities and global regulatory teams.
• Contribute to the success of a multinational pharmaceutical organization with a strong compliance culture.
• Gain exposure to complex regulatory frameworks and cross-functional collaboration.
• Be part of a high-impact role based in Delhi with visibility across global operations.

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