Manager Regulatory Affairs - Delhi

our future employee; Delhi; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Delhi is seeking a seasoned Regulatory Affairs professional to lead timely regulatory actions, registrations, and submissions across NCEs and line extensions.

The role involves liaising with Health Authorities, ensuring rapid yet compliant decisions, and maintaining alignment with global timelines. The ideal candidate has 8–10 years of pharma regulatory experience, strong analytical abilities, and a proven track record with regulators.

Qualifications

• Bachelor’s degree in pharmacy or similar medical education.
• Pharma experience with regulatory focus in a multi-national for 8–10 years.
• Proven track record of liaising with Health Authority.
• Solid understanding of D&C Act and Rules.
• Understanding of working practices at Health Authority.
• Experience of direct interactions with Regulatory Authorities.
• Analytical skills
• Position based in Delhi

Responsibilities

• Registration of NCE and line extensions for the therapeutic area of responsibility.
• Strategies compliant with regulations; liaise with Health Authority for earliest submission and registration in the country.
• Follow-up regulatory approvals for products per registration plan.
• Liaise with Health Authority and engage in discussions with Senior Regulatory officials.
• Ensure earliest submission and approvals for CMC changes per global timelines.
• Renewal on time to ensure uninterrupted availability of products in the country.
• Amendments and updates approved on time to ensure study continuity and timely notification of notifiable updates.
• Follow-up on submitted applications at Health Authority.
• Regulatory Intelligence: share updates with local and global teams; update RI tool and RIN database.

Skills

Liaising with Health Authority

Analytical skills

Education

Bachelor's degree in Pharmacy

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