Manager Regulatory Affairs - Delhi

Boehringer Ingelheim GmbH; Delhi; On-site; INR 1,800,000 - 2,500,000; Full time

Job summary

Boehringer Ingelheim GmbH in Delhi is seeking an experienced Regulatory Affairs professional to manage registrations for NCEs and line extensions and drive timely regulatory actions. This role focuses on coordinating strategies compliant with regulations and liaising with Health Authorities while ensuring rapid adoption of CMC changes within global timelines.

You will collaborate with local and global teams, oversee regulatory intelligence, and manage approvals across a multinational framework

Qualifications

• Bachelor’s degree in pharmacy or equivalent medical education.
• 8–10 years of regulatory experience in a multinational setting.
• Proven liaison experience with health authorities.
• Understanding of the D&C Act and rules; experience engaging health authorities.

Responsibilities

• Register NCEs and line extensions for the therapeutic area of responsibility.
• Strategies compliant with regulations; liaise with Health Authorities for early submissions and registrations.
• Follow-up regulatory approvals per registration plan.
• Liaise with Health Authority regularly and engage in discussions with senior regulatory officials.
• Ensure timely submissions and approvals for CMC changes per global timelines.
• Renewals to ensure uninterrupted product availability in the country.
• Monitor and update submissions and notify notifiable updates.
• Follow-up on submitted applications at Health Authority.
• Regulatory intelligence: share updates with local/global teams and log them in RI tooling.

Skills

Regulatory liaison

Analytical skills

Stakeholder management

Education

Bachelor's degree in Pharmacy or relevant medical education

Tools

RINTOOL

Job description

Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner

Tasks & Responsibilities

• Registration of NCE and line extensions for therapeutic area of responsibility
• Strategies compliant with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country.
• Follow-up regulatory approvals for the products per registration plan.
• Liaise with Health Authority regularly and engage in impactful discussion with Senior Regulatory officials.
• Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines.
• Renewal on time to ensure uninterrupted availability of products in the country.
• Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates.
• Follow-up on submitted applications at HA.
• Regulatory Intelligence, ensure all regulatory updates are shared with local and global team in timely manner. Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database.

Requirements

• Education: Bachelor’s degree in pharmacy or similar medical education.
• Pharma experience with regulatory focus in a multi-national for at least 8-10 years.
• Proven track record of Strong Liaising experience in the health authority
• Solid understanding of D&C Act and Rules.
• Understanding of working practices at HA.
• Experience of direct interactions with Regulatory Authorities.
• Analytical skills
• Position is based in Delhi