Regulatory Submission Manager
Job Description:
* This role is responsible for leading the global marketing authorization submission management processes.
* The Associate will work with GRA-CMC Scientists to create and manage submission content, provide guidance on structure and content placement within CTD registration submissions.
Key Responsibilities:
1. Triaging and managing communications between Lilly Affiliates, GRA-CMC Scientists, Specialists, and Quality/Reg Representatives.
2. Developing project management expectations across projects using GRA-CMC submission process expertise and IT tools.
3. Communicating submission tracking requirements to internal customers based on implementation and supply chain needs.
Requirements:
* Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related field).
* Knowledge of pharmaceutical drug development or industry-related experience preferred.
Benefits:
* A premium campus workspace with flexible hybrid working, healthcare, pension and life assurance, subsidised canteen, onsite gym, travel subsidies and on-site parking.
* Inhouse People Development services and wellbeing initiatives are part of the benefits that enhance the career experience for our colleagues.
Preferred Qualifications:
* Drug development process or industry-related experience.
* Knowledge of agency submission procedures and standards; awareness of emerging electronic submission standards.
Primary Skills:
* Strong written, oral, and presentation skills.
* Negotiation and influence skills.
* Attention to detail and ability to prioritize effectively.
* Proven effective teamwork skills and ability to adapt to diverse interpersonal styles.
What We Offer:
* Opportunities for professional growth and development.
* Competitive salary and benefits package.
* Flexible working arrangements.