Head of Regulatory Affairs

Company Description

At Zenovel, we specialize in delivering high-impact solutions across three critical areas of the pharmaceutical industry: Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Regulatory Affairs. With over 20 years of global experience, we help pharma and biotech companies ensure their trials, facilities, and products meet international regulatory standards efficiently and effectively. Our core services include risk-based monitoring, audits, facility setup, strategic regulatory planning, and dossier submission. Zenovel is committed to turning regulatory complexity into competitive advantage, aiding partners in scaling safely, compliantly, and globally.

Role Description

This is a full-time on-site role for a Head of Regulatory Affairs, located in Ahmedabad. The Head of Regulatory Affairs will oversee and manage regulatory compliance, develop and implement regulatory strategies, ensure adherence to regulatory requirements, and lead the submission of regulatory dossiers. Responsibilities include strategic regulatory planning, compliance audits, facilitating product registrations with various international regulatory bodies, team leadership, and maintaining up-to-date knowledge of relevant laws and regulations.

Qualifications

• Experience in Regulatory Compliance and Regulatory Requirements
• Proficiency in Regulatory Strategy and Regulatory Affairs
• Skills in Regulatory Submissions and Dossier Compilation
• Excellent leadership and team management abilities
• Strong communication and interpersonal skills
• Proven ability to work effectively in a fast-paced environment
• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field
• Advanced knowledge of global regulatory standards and procedures
• Experience in the pharmaceutical or biotech industry is highly desirable