Associate/Senior Associate in Research and Development at Eli Lilly
Organization:
Eli Lilly and Company
Location:
Bangalore, Karnataka, India
Position Type:
Full-Time (Associate/Senior Associate)
Qualification:
- Essential:
- B.Pharm, M.Pharm, M.Sc, B.Sc, Ph.D
- Experience:
- 1 to 2 Years in a relevant field
Salary:
Not Disclosed
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company dedicated to discovering and developing innovative medicines. With a strong focus on research and development, Lilly aims to address some of the world’s most pressing health challenges. The company’s commitment to quality and innovation has established it as a leader in the pharmaceutical industry, particularly in regulatory affairs and drug development.
Position Overview: Associate/Senior Associate in Global CMC Regulatory Affairs (GRA)
Eli Lilly is seeking a dedicated and detail-oriented Associate/Senior Associate to join their Global CMC Regulatory Affairs (GRA) team in Bangalore. This role is integral to the global marketing authorization submission processes, working closely with CMC RA Scientists and other internal teams to ensure compliance with regulatory standards.
As part of the GRA team, you will lead and manage submission content for clinical studies and manufacturing changes, assist with Ministry of Health responses, and collaborate with various stakeholders across geographies to maintain Lilly’s high standards in drug development and regulatory affairs.
Key Responsibilities
Regulatory and Drug Development Expertise
- Lead the CMC Submission Management Process:
- Ensure compliance with global regulatory requirements for marketing authorization submissions.
- Partner with CMC RA Scientists to plan and prepare submission content for clinical studies and manufacturing changes.
- Communication and Collaboration:
- Manage effective communication between Lilly affiliates, GRA-CMC Scientists, and other internal teams to facilitate smooth submission processes.
- Assist in the preparation and coordination of responses to queries from Ministries of Health worldwide.
Leadership and Collaboration
- Foster Open Communication:
- Encourage an open environment within the Global Regulatory Area for discussion and decision-making related to submission management and compliance.
- Problem-Solving and Issue Resolution:
- Demonstrate strong problem-solving skills to address regulatory issues across functions and geographies.
- Guide life-cycle management processes, ensuring compliance and effective resolution of any issues that arise.
Qualifications
Educational Background
- Bachelor’s degree in a scientific or health sciences discipline (e.g., Pharmacy, Chemistry).
- Advanced degrees (M.Pharm, M.Sc, Ph.D.) are preferred.
Experience
- 1 to 2 years of experience in pharmaceutical drug development, regulatory affairs, or related industry roles is preferred.
Key Skills
- Communication:
- Strong written, spoken, and presentation skills are essential.
- Attention to Detail:
- A meticulous approach to managing regulatory submissions and documentation.
- Teamwork:
- Ability to work effectively in a collaborative environment.
- Regulatory Knowledge:
- Familiarity with regulatory standards and the ability to operate within a regulated environment.
Physical and Mental Requirements
- Ability to work at a computer for extended periods.
- Strong focus on tasks with the ability to follow detailed instructions.
- Effective verbal communication and comprehension skills are essential for successful interaction with team members and stakeholders.
Why Join Eli Lilly?
Joining Eli Lilly as an Associate/Senior Associate offers an exceptional opportunity to be part of a global leader in pharmaceutical research and development. At Lilly, you will be at the forefront of ensuring compliance with global regulatory standards, contributing to life-saving medicines reaching the market.
The role offers a dynamic work environment where your expertise in regulatory affairs will be highly valued. You will collaborate with professionals across the globe, driving innovation and maintaining the integrity of Lilly’s drug development processes.
How to Apply
Interested candidates should submit their resumes along with a cover letter highlighting their qualifications and interest in the role. Eli Lilly is an equal opportunity employer, and we encourage applications from candidates who are passionate about advancing their careers in pharmaceutical research and development.
Apply today to make a significant impact on global healthcare with Eli Lilly!
