Senior Manager

Sun Pharma; Gurugram District; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Sun Pharma in Haryana, India seeks a senior Regulatory Affairs lead to manage regulatory activities for solid oral dosage forms, ensuring alignment with USFDA expectations and global regulatory standards.

You will drive strategies to maintain approvals, enable timely launches, and collaborate with marketing, manufacturing, and quality teams to resolve complex regulatory challenges.

Qualifications

• 12–20 years of experience in pharmaceutical regulatory affairs.
• Proven understanding of USFDA guidelines and drug approval processes.
• Experience leading regulatory projects from concept to execution.

Responsibilities

• Manage regulatory affairs for solid oral dosage forms and ensure USFDA compliance.
• Develop strategies to maintain approvals and enable timely product launches.
• Collaborate with marketing, manufacturing, and quality to resolve regulatory issues.
• Provide expert regulatory guidance to internal stakeholders.

Skills

Regulatory affairs

USFDA regulations

Cross-functional collaboration

Job description

Roles and Responsibilities :

• Manage regulatory affairs for solid oral dosage forms, ensuring compliance with USFDA regulations.
• Develop and implement effective strategies to maintain regulatory approvals and ensure timely product launches.
• Collaborate with cross-functional teams to resolve regulatory issues and provide guidance on product development.
• Provide expert advice on regulatory requirements to internal stakeholders, including marketing, manufacturing, and quality control.

Job Requirements :

• 12-20 years of experience in pharmaceutical industry with a focus on solid orals and regulatory affairs.
• Strong understanding of USFDA regulations and guidelines governing drug products.
• Proven track record of successfully managing complex regulatory projects from concept to execution.