Manager/Sr. Manager - Regulatory Affairs
Location: Gurgaon, Haryana, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-72432
Purpose:
Responsible for regulatory planning to meet affiliate and responsible countries' business needs, ensuring compliance with regulatory tools and functional processes. Manage regulatory activities for new product registrations, indications, and product maintenance. Build partnerships with regulatory authorities and stay updated on local and global regulatory trends impacting business opportunities.
Primary Responsibilities:
1. Regulatory Planning:
Regulatory Plan Development:
Develop and review regulatory strategies, aligning with country regulations and MOH processes.
Ensure Regulatory Plan aligns with Product Teams, Area strategies, and business plans.
Process Management:
Coordinate with cross-functional teams to ensure timely availability of documents and requirements.
Provide regulatory expertise to cross-functional teams to meet timelines.
Regulatory Tools:
Update regulatory data in tools, ensuring accuracy and communication with stakeholders.
2. Submissions and Approvals:
Dossier Preparation:
Prepare high-quality regulatory dossiers within planned timelines.
Obtain necessary documents and ensure compliance with regulatory requirements.
Regulatory Approval:
Gain approvals from Drug Regulatory Agencies (DRA) to meet product launch plans.
Ensure timely responses to MOH queries and archive approval documents.
Metrics Review:
Prepare and communicate periodic regulatory performance reports to local, Area, and Regional management.
3. Regulatory Compliance:
Compliance Maintenance:
Maintain compliance for marketed products, including labeling, chemistry, and manufacturing changes.
Conduct periodic self-audits and take corrective actions based on regulatory audit findings.
Good Regulatory Practices (GRP):
Develop and implement SOPs in line with Global Regulatory Affairs policies and local regulations.
Complete Regulatory Core Curriculum and Good Regulatory Practices training.
4. Regulatory Influence:
External Relations:
Build relationships with key regulatory officials to foster a positive regulatory environment.
Stay updated on local regulatory changes and communicate potential impacts.
Internal Influence:
Build functional partnerships within the affiliate to maximize regulatory value.
Educate affiliates on regulatory trends and the value regulatory functions bring to business.
5. Additional Responsibilities (if applicable):
Support Health Economic data for DRA price negotiations.
Provide regulatory support for locally manufactured products and clinical trials.
Fulfill responsibilities of ALRP/Alternate ALRP/Delegate ALRP as assigned, including compliance with regulatory requirements and ensuring accurate product information submission.
Minimum Qualification Requirements:
Education: B.Pharm, M. Pharm, BSc, Master’s Degree in Chemistry, Biotechnology, or related fields, or MD (licensed as per local regulations).
Experience: Minimum 3 years in regulatory affairs or related fields.
Knowledge:
In-depth knowledge of local product registration requirements and corporate regulatory policies.
Understanding of local business decision-making processes affecting regulatory strategies.
Additional Preferences:
Proficiency in written and spoken English; additional languages are a plus.
Strong project management, analytical, and communication skills.
Ability to handle multi-tasking, conflict resolution, and possess negotiation skills.
Customer focus with creative thinking and problem-solving abilities.
Lilly’s Commitment:
Lilly is committed to providing equal opportunities and actively engaging individuals with disabilities in the workforce. If accommodation is required for the application process, please visit Lilly Accommodation Request.
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