Senior Regulatory Affairs Specialist

1 week ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 24,00,000
Job Description:

We are seeking a highly skilled Regulatory Associate to join our team. As a key member of our regulatory affairs department, you will be responsible for managing global marketing authorization submission processes and providing expertise on structure and content requirements for CTD registration submissions.

The successful candidate will have a strong working knowledge of internal procedures, guidelines, and regulatory precedents. They will also possess excellent communication and problem-solving skills, with the ability to effectively prioritize tasks and manage multiple projects simultaneously.

Responsibilities include:

• Providing knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards
• Leading CMC submission management process and preparing CTD content consistent with approved manufacturing changes
• Partnering with CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes
• Implementing and interpreting global regulations and guidances, and ensuring final document content and structure align with local regulatory requirements

Required Skills and Qualifications:

• Bachelor's degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)
• Knowledge of pharmaceutical drug development or industry-related experience preferred
• Strong understanding of regulatory procedures, guidances, and precedence
• Excellent communication, problem-solving, and project management skills
• Ability to operate and manage operational requirements in a regulated environment

Benefits:

• Competitive salary and benefits package
• Opportunities for career growth and professional development
• Collaborative and dynamic work environment

Others:

Lilly is an equal opportunity employer committed to diversity and inclusion. We welcome applications from qualified candidates who share our values and commitment to making life better for people around the world.

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