Regulatory Affairs CMC Specialist at Eli Lilly
| Job Title | Regulatory Affairs CMC Specialist |
|---|---|
| Company | Eli Lilly |
| Experience Required | 2 – 4 Years |
| Salary Range | 4 – 8.5 Lacs per annum |
| Location | Bangalore |
| Education Requirements | B.Pharm, M.Pharm, Pharm.D, M.Sc, Life Sciences |
| Application Mode | Online |
| Job Highlights | Work/Life Balance, Flexibility, Problem Solving, Time Management |
| Key Skills | CMC Documentation, Compliance, Project Management, Collaboration |
Join Eli Lilly as a Regulatory Affairs CMC Specialist
The Regulatory Affairs CMC Specialist role at Eli Lilly in Bangalore is a unique opportunity to engage in regulatory activities for Chemistry, Manufacturing, and Controls (CMC) in a global pharmaceutical setting. This position is ideal for candidates with a regulatory or life sciences background who are looking to develop their expertise in regulatory document management and compliance within an international framework. Regulatory Affairs CMC Specialist at Eli Lilly
Why Choose Eli Lilly?
Eli Lilly is a global leader in healthcare, dedicated to advancing medical science and regulatory practices. This role not only provides an opportunity to work in a collaborative environment but also emphasizes work/life balance, flexibility, and growth opportunities for career advancement in regulatory affairs. Regulatory Affairs CMC Specialist at Eli Lilly
Role Overview
As a Regulatory Affairs CMC Specialist, your core responsibilities include supporting CMC documentation for various regulatory submissions such as new product registrations, renewals, and post-approval changes. You’ll work closely with global teams to prepare, review, and coordinate essential regulatory documents to meet compliance standards across regions. Regulatory Affairs CMC Specialist at Eli Lilly
Key Responsibilities Breakdown
1. Regulatory Document Preparation
- Module 1 CTD Development: Assist in creating and managing Module 1 documentation within the Common Technical Document (CTD) framework.
- Global Documentation: Prepare Certificates of Analysis (COAs), FDA Certificates of Pharmaceutical Product (CPPs), GMP Certificates, and other regulatory declarations.
- Documentation Management: Ensure all documents adhere to the required regulatory standards and are updated according to manufacturing changes.
Regulatory Affairs CMC Specialist at Eli Lilly
2. Quality and Compliance Assurance
- Regulatory Compliance: Ensure all documentation is consistent with regulatory requirements set by FDA, EMA, ICH, and Good Clinical Practice (GCP) guidelines.
- Documentation Standards: Maintain accuracy in classifications, naming conventions, and record-keeping. Regulatory Affairs CMC Specialist at Eli Lilly
3. Project Management and Coordination
- Product Registrations: Oversee global product registrations and renewals, keeping in contact with regulatory representatives.
- Submission Tracking: Monitor and record submission activities to ensure timelines are met and project progress is accurately tracked.
4. Collaboration and Communication
- Liaison with Agencies: Coordinate with U.S. and international regulatory agencies and consulates to meet submission and registration deadlines.
- Team Collaboration: Act as a key point of contact among Lilly’s affiliates, Regulatory Scientists, and Manufacturing sites, ensuring efficient documentation workflows. Regulatory Affairs CMC Specialist at Eli Lilly
Ideal Candidate Profile
Educational Background
Candidates with a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or related disciplines are preferred.
Experience and Skills
- Regulatory Knowledge: Familiarity with global regulatory systems, such as CTD formatting and ICH guidelines, is essential.
- Project Management Skills: Experience with project coordination, particularly with regulatory timelines and document tracking.
- Technical Skills: Proficiency in Microsoft Office (Word, Excel) and experience with SharePoint and Regulatory Information Management (RIM) systems.
- Interpersonal Skills: Ability to work effectively within a team, manage compressed timelines, and prioritize multiple tasks.
How to Position Yourself for Success
To stand out as a strong candidate for this role:
- Showcase Regulatory Experience: Highlight your familiarity with CTD and regulatory documentation standards.
- Emphasize Compliance and Quality Assurance Skills: Share examples of ensuring compliance with regulatory standards in previous roles.
- Project Management Abilities: Mention any relevant experience in managing timelines and coordinating projects across different stakeholders.
- Communication and Team Collaboration: Discuss your experience in collaborating with internal teams and external agencies, emphasizing your ability to manage documentation workflows and meet deadlines.
Regulatory Affairs CMC Specialist at Eli Lilly
Why This Role Could Be Right for You
The CMC Specialist role at Eli Lilly offers an excellent chance to engage in meaningful regulatory work while gaining exposure to global pharmaceutical standards. With an emphasis on compliance, quality, and team collaboration, this role is perfect for those looking to further their career in regulatory affairs within a supportive environment that values flexibility, work/life balance, and professional development. If you’re ready to take on the challenge of regulatory documentation in a global setting, apply today to join Eli Lilly’s team!
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