Regulatory Affairs Manager

Dear Candidate,

We are hiring for the Regulatory Affairs role-handling the below job responsibilities,

Job Title: Regulatory Affairs Manager

Company: Brinton Pharmaceuticals Ltd.

Location: Kharadi, Pune

Salary: Best in Industry

Joining: Immediately

Position Overview:

Regulatory Affairs Manager to lead efforts focused specifically on product approvals, price compliance, and regulatory risk mitigation in

Key Responsibilities:

1. Product Registration & Approvals:

• Independently manage the full lifecycle of product dossiers and lead registration, renewals, and post-approval updates.
• Identify, analyse, and communicate relevant domestic and international regulations impacting product registration for all assigned markets, ensuring the team is informed of regulatory changes affecting submission strategies.
• Lead the preparation and coordination of regulatory submissions for each product launch, ensuring all requirements and deadlines are met for timely approvals.
• Oversee approval timelines, identify possible delays, and implement corrective actions to meet deadlines.

1. Team Leadership & Cross-Functional Coordination:

• Manage, train, and mentor the regulatory team for performance and capability enhancement.
• Collaborate with cross-functional teams to ensure alignment with regulatory objectives.
• Engage in cross-functional collaboration to strategize the preparation and submission of product registration dossiers.
• Follow up with domestic/international regulatory agencies to secure early approval and marketing authorization that align with the company's global expansion and marketing plans.

1. Audit Readiness and Documentation:

• Maintain regulatory documentation in audit-ready condition for internal, partner, or government audits.
• Maintain structured, compliant filing systems for domestic/international product dossiers and communication logs.
• Documentation preparation & Validations ensuring completeness and accuracy.

1. Regulatory Intelligence & Risk Management:

• Monitor changes in regulatory guidelines, including gazette notifications, policy changes, and NPPA updates.
• Analyze potential risks and proactively implement compliance measures to mitigate disruptions to product sales or availability.

Qualifications:

• Education: Pharma/Science background

• Experience: 6+ years in Regulatory Affairs

• Skills Required:

• The candidate must master the standards behind product quality, efficacy, and safety. This also means interpreting requirements for things like promotional literature, product labels, and information leaflets—and using this knowledge to help products succeed.

To Apply:

Regulatory Affairs Manager