Job Title: Manager/Sr. Manager - Regulatory Affairs
Location: Gurgaon, Haryana, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-72432
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, with employees across the globe dedicated to discovering and delivering life-changing medicines. Our efforts focus on not only groundbreaking therapies but also improving disease understanding, supporting the communities we serve, and advancing healthcare innovation. We are committed to hiring individuals who want to make a difference in the lives of patients worldwide.
The Manager/Sr. Manager - Regulatory Affairs will be responsible for overseeing the regulatory processes related to the registration and maintenance of pharmaceutical products in India. This includes ensuring compliance with local regulations, managing submissions to regulatory authorities, and maintaining close relationships with key regulatory bodies. This role involves developing regulatory strategies for new products, managing regulatory tools, and ensuring the timely approval and maintenance of product registrations in alignment with the business needs of the affiliate.
Regulatory Plan Development:
Develop, review, and recommend the optimal regulatory strategy for product submissions, including timelines, for assigned portfolio. Ensure regulatory strategies are aligned with Product Teams, Area strategies, and the country’s business plans.
Process Management:
Coordinate with cross-functional teams within the affiliate, including sites and corporate functions, to ensure timely preparation of regulatory dossiers and required documents.
Regulatory Tools:
Maintain timely and accurate updates in regulatory tools to support global processes, ensuring that data is properly communicated to stakeholders.
Dossier Preparation:
Prepare and submit quality regulatory dossiers for new products, product line extensions, or new indications. Ensure all submissions meet regulatory requirements and timelines.
Regulatory Approval:
Obtain regulatory approval from the Drug Regulatory Authority (DRA) for product launches, renewals, and variations. Respond to queries and track post-approval commitments.
Metrics Review:
Prepare and communicate regular regulatory reports on submissions, approvals, and overall regulatory performance to local management.
Compliance Maintenance:
Ensure ongoing regulatory compliance for marketed products, including managing product variations, labeling, and packaging development as per local regulations. Perform regular audits and take corrective actions when needed.
Good Regulatory Practices (GRP):
Develop, implement, and update standard operating procedures (SOPs) to ensure adherence to local and global regulatory policies. Complete required training related to regulatory quality systems and GRP.
External Relations:
Establish and nurture relationships with key regulatory officials to influence regulatory decisions and foster a positive environment for business and research.
Regulatory Environment Updates:
Stay informed of any changes in local regulations and communicate potential impacts to the business.
Internal Influence:
Collaborate with internal teams to ensure alignment and understanding of regulatory requirements, adding value to business decisions.
Health Economics Support:
Provide support in health economics data related to drug price negotiations with regulatory bodies.
Local Manufacturing Support:
Provide regulatory support for locally manufactured products and clinical trials, including regulatory approvals and clinical trial licenses.
Affiliate Product Information:
Ensure that all affiliate product information complies with local and regional regulatory requirements and is submitted within designated timelines.
Educational Background:
B.Pharm, M.Pharm, B.Sc., Master’s Degree in Chemistry, Biotechnology, or related field; MD (if applicable) as per local regulations.
Experience:
A minimum of 3 years of experience in regulatory affairs or related roles, preferably in the pharmaceutical industry.
Regulatory Knowledge:
In-depth understanding of local regulations for pharmaceutical product registration and maintenance. Knowledge of corporate regulatory policies and how they apply locally.
Lilly is committed to diversity, equity, and inclusion. We welcome applications from individuals with diverse backgrounds and experiences. If you require accommodation for the application process, please complete the accommodation request form on the Lilly careers website.
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