Regulatory Affairs Manager

Key Responsibilities:

1.

• 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.

2.

• 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.

3.

• 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.

4.

• 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.