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Vehere
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Vehere - Director - Regulatory Affairs (15-17 yrs)
Vehere
posted 12hr ago
Director - Regulatory Affairs
About the job:
Job Summary:
- The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets.
- This role will involve managing regulatory submissions, advocating compliance standards, collaborating with cross-functional teams, and staying ahead of changes in relevant regulations and industry trends.
Key Roles and Responsibilities:
Regulatory Strategy & Leadership:
- Develop and implement regulatory strategies for the company's products, services, and operations across multiple regions.
- Act as the main point of contact for all regulatory matters within the company and with external regulatory bodies.
- Provide thought leadership on Indian regulatory initiatives, ensuring compliance with laws and industry standards.
Regulatory Advocacy:
- Represent the company in Ministries, industry groups and forums, advocating for policies and regulations that support innovation while ensuring compliance.
- Engage with external regulatory bodies to resolve compliance issues and facilitate approvals.
- Monitor trends in regulatory changes and proactively advise senior management on potential impacts on business operations.
Regulatory Compliance Management:
- Oversee regulatory submissions (e.g., certifications, clearances, approvals) for new products and technologies in different markets.
- Monitor evolving regulatory requirements and ensure that the company adapts promptly to maintain compliance.
- Prepare and file regulatory documents, reports, and applications with government agencies.
- Conduct risk assessments related to regulatory matters and implement mitigation strategies.
Cross-functional Collaboration:
- Work closely with product development, legal, and quality assurance teams to ensure that regulatory compliance is integrated into all stages of product lifecycle.
- Provide regulatory guidance and expertise to product development teams to ensure that all designs and features meet regulatory standards.
- Lead and participate in internal and external audits, inspections, and regulatory body interactions.
Documentation & Reporting:
- Ensure accurate and up-to-date regulatory documentation and records.
- Produce regular reports for senior management on the status of regulatory compliance and any potential risks.
- Maintain regulatory databases, ensuring that all filings and communications with regulatory bodies are organized and accessible.
Training & Development:
- Provide training to internal teams on regulatory requirements and compliance processes.
- Stay current with industry trends, new regulations, and emerging technologies, and communicate these to internal stakeholders.
Skills and Experience:
- Graduation or Post Graduation degree in a relevant field.
- 15+ years of experience in regulatory affairs, with at least 5 years in a senior position within the technology sector.
- Exposure working with Ministry of Home (MHA), National Cyber Coordination Centre, MEITY, DOT, Ministry of External Affairs (MEA).
- Proven experience with regulatory submissions and navigating complex regulatory landscapes in global markets.
- Strong understanding of Indian regulations related to technology products, including hardware, software, telecommunications, data privacy, and cybersecurity.
- Deep knowledge of Indian regulatory requirements, processes, and standards for technology products.
- Excellent communication, negotiation, and interpersonal skills to interact with senior management, regulatory authorities, and external stakeholders.
- Strong problem-solving and critical-thinking abilities to manage complex regulatory challenges.
- Ability to work cross-functionally and lead teams to achieve regulatory compliance goals
Functional Areas: Pharma/Healthcare
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