Responsibilities :

- Regulatory Strategy: Develop and execute regulatory strategies for product registration and approval in ROW markets. Stay updated on evolving regulatory requirements and assess potential impact on business operations.

- Product Registration: Lead and oversee the process of product registration, including the preparation and submission of regulatory dossiers to health authorities in different countries. Ensure timely and successful approvals.

- Regulatory Submissions: Prepare, review, and submit high-quality regulatory submissions, including applications, variations, renewals, and post-approval amendments, as required by MOHs.

- Regulatory Intelligence: Monitor and analyze regulatory trends, guidelines, and changes in ROW countries to proactively address potential challenges and opportunities.

- Cross-Functional Collaboration: Work closely with internal departments, including R&D, Quality Assurance, Manufacturing, and Marketing, to gather necessary information for regulatory submissions and compliance.

- Risk Assessment: Conduct risk assessments related to regulatory compliance and develop mitigation strategies to ensure alignment with local regulations.

- Regulatory Compliance: Ensure adherence to regulatory norms and standards established by MOHs in ROW countries. Implement processes to maintain ongoing compliance throughout the product lifecycle.

- Regulatory Audits and Inspections: Prepare for and manage regulatory audits and inspections by health authorities in ROW markets. Address any findings or observations and implement corrective actions.

- Regulatory Training: Provide training and guidance to internal teams regarding regulatory requirements, processes, and best practices.

- External Stakeholder Engagement: Establish and maintain strong relationships with health authorities, regulatory agencies, and industry associations in ROW countries. Represent the company in relevant regulatory forums.

- Strategic Partnerships: Collaborate with local regulatory consultants, legal advisors, and third-party service providers as needed to facilitate efficient product registration and compliance.

- Documentation Management: Ensure accurate and organized maintenance of regulatory documents, correspondence, and records in accordance with regulatory standards.

Qualifications and Skills :

- Extensive experience (typically 5+ years) in regulatory affairs within the pharmaceutical industry, with a focus on ROW markets.

- In-depth knowledge of international drug regulations, guidelines, and requirements, particularly those set by MOHs in various countries.

- Proven track record of successful product registrations and regulatory approvals in multiple ROW markets.

- Strong analytical and problem-solving skills, with the ability to interpret and apply complex regulatory guidelines.

- Excellent communication and negotiation skills to interact effectively with internal teams, health authorities, and external partners.

- Project management expertise to handle multiple product registrations simultaneously and meet deadlines.

- Leadership and team management skills to lead a regulatory team and drive regulatory initiatives.

- Proficiency in regulatory software, document management systems, and databases.

- Strong attention to detail and a commitment to maintaining high standards of regulatory compliance.

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