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Associate Director-Regulatory Liasoning
8-11 years
Panipat, Yamunanagar, Faridabad + 3 more
1 vacancy
Associate Director-Regulatory Liasoning
Eli Lilly and Company
posted 5d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Regulatory Compliance: Ensure that all regulatory activities comply with local regulations and guidelines set by CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other relevant authorities.
- Liaison with Regulatory Bodies: Act as the primary point of contact between the company and regulatory authorities, facilitating smooth communication and addressing any regulatory queries or issues.
- Product Registration: Manage the registration process for new products, line extensions, and new indications, ensuring timely submission and approval of dossiers.
- Documentation: Prepare, review, and submit regulatory documents, including applications, variations, renewals, and responses to queries from regulatory authorities.
- Regulatory Strategy: Develop and implement regulatory strategies to support the companys business objectives and ensure successful product registrations.
- Cross-functional Collaboration: Work closely with internal departments such as R&D, Quality Assurance, and Marketing to ensure alignment on regulatory requirements and timelines.
- Regulatory Intelligence: Monitor and analyze changes in regulatory policies and guidelines, providing updates and recommendations to the management team. Keeping track of all relevant updates and maintenance of related repositories.
- Training and Development: Provide training and guidance to internal teams on regulatory requirements and best practices.
- Stakeholder Management: Build and maintain relationships with key stakeholders, including government officials, industry associations, and other relevant entities.
- Risk Management: Identify potential regulatory risks and develop mitigation strategies to ensure compliance and minimize impact on business operations.
- Bachelor s degree in pharmacy, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 8 years of experience in regulatory affairs within pharmaceutical industry preferably in a MNC.
- In-depth knowledge of Indian regulatory requirements and guidelines, particularly those of CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other relevant authorities.
- Strong communication and interpersonal skills, with the ability to build and maintain relationships with regulatory authorities.
- Excellent organizational and project management skills, with the ability to manage multiple tasks and deadlines.
- Proficiency in regulatory documentation and submission processes.
- Experience in regulatory liaison roles or similar positions.
- Familiarity with global regulatory requirements and guidelines.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
Employment Type: Full Time, Permanent
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Anonymous · Technology / IT
in Gurgaon/Gurugram
Work ife balence. Good employee benefits.
No growth to India employeees. Weak HR, Boss oriented company. HR doesn't protect employees from bad bosses.
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