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Job Title: Associate Director - Regulatory Affairs and Liaisoning
Location: Gurgaon, Haryana, India
Reports to: Director - Regulatory Affairs & Pharmacovigilance
Job Summary: Associate Director - Regulatory Affairs will be responsible for regulatory liasoning, managing and coordinating regulatory activities with key regulatory bodies in India, including the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare (MoHFW), Department of Pharmaceuticals, National Institute of Biologicals (NIB), Indian Pharmacopoeia Commission (IPC) Ghaziabad, Central Drugs Testing Laboratory (CDTL), and other relevant government authorities at both central and state levels. The role involves ensuring compliance with local regulations, facilitating communication between the company and regulatory authorities, and supporting the registration and maintenance of pharmaceutical products.
Key Responsibilities:
- 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 company's 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.
Qualifications:
- 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.
Preferred Skills:
- 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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