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03/08 HR
HR at Deco De Trend

Views:240 Applications:37 Rec. Actions:Recruiter Actions:0

Deco De Trend - Regulatory Head - ROW Market (5-7 yrs)

Chennai Job Code: 1296618

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.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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