Roles & Responsibilities:
• Develop and implement regulatory strategies for new and existing products, including NDA/sNDA filings and product lifecycle maintenance.
• Manage ongoing renewals, variations, labeling updates, and compliance with local Health Authority requirements.
• Collaborate with global and local teams to provide regulatory input during product development, launch planning, and marketing campaigns.
• Monitor regulatory legislation, marketing applications, and submissions to ensure timely approvals.
• Liaise and negotiate with authorities to secure regulatory approvals efficiently.
• Review and approve labeling, advertising, and promotional materials for compliance.
• Support cross-functional teams with regulatory documentation, such as Market Standing Certificates, GMP, Manufacturing Licenses, and other regulatory certificates.
• Ensure compliance with internal processes, company policies, and local regulatory requirements.
Qualification:
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
Experience:
• Experience in new drug registration, clinical trials, and regulatory submissions in India.
• Exposure to cross-functional collaboration with RA, Medical Affairs, Marketing, Quality, and Global Regulatory teams.
Skills:
• Strong knowledge of regulatory affairs processes, local regulations, and Health Authority requirements.
• Excellent communication, negotiation, and interpersonal skills.
• Project management skills and ability to work in a fast-paced environment.
• Analytical and problem-solving abilities.
• Domain knowledge of subregion country regulations is a plus.
About the Organisation:
Domnic Lewis Pvt. Ltd is a leading healthcare and pharmaceutical company focused on delivering high-quality, compliant solutions across India and international markets, emphasizing innovation, regulatory excellence, and cross-functional collaboration.
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