Regulatory Affairs Associate

HR Footprints; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

HR Footprints in Hyderabad, India is seeking an experienced Regulatory Affairs professional to manage drug regulatory submissions and maintain compliance across the product lifecycle.

The role requires 5–7 years in pharma regulatory affairs, deep knowledge of USFDA guidelines, and hands-on experience in dossier preparation, eCTD submissions, and filing variations.

Qualifications

• 5-7 years of experience in pharmaceutical industry with expertise in drug regulatory affairs.
• Strong understanding of USFDA guidelines and regulations governing drug development process.
• Proficiency in preparing dossiers for regulatory submissions, including eCTD format.

Responsibilities

• Manage drug regulatory affairs, including dossier preparation, submission, and approvals from US FDA (US Food and Drug Administration).
• Coordinate with cross-functional teams to ensure timely completion of regulatory requirements throughout the product lifecycle.
• Prepare and review variation applications, renewals, and other documentation related to drug regulations.
• Provide guidance on regulatory compliance matters to internal stakeholders.

Skills

Regulatory affairs

US FDA guidelines

eCTD submissions

Job description

Roles and Responsibilities :

• Manage drug regulatory affairs, including dossier preparation, submission, and approvals from US FDA (US Food and Drug Administration).
• Coordinate with cross-functional teams to ensure timely completion of regulatory requirements throughout the product lifecycle.
• Prepare and review variation applications, renewals, and other documentation related to drug regulations.
• Provide guidance on regulatory compliance matters to internal stakeholders.

Job Requirements :

• 5-7 years of experience in pharmaceutical industry with expertise in drug regulatory affairs.
• Strong understanding of USFDA guidelines and regulations governing drug development process.
• Proficiency in preparing dossiers for regulatory submissions, including eCTD format.