Job Description
**Job Summary:** Regulatory Associate (RA) role in Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE) leads global marketing authorization submission management processes.
We are a global healthcare leader headquartered in Indianapolis, Indiana, with a diverse team of over 1,600 employees across 38 nationalities. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
The CMC Regulatory Associate will lead the various aspects of global marketing authorization submission management processes, partnering with GRA-CMC Scientists to create and manage RIM submission content, and provide guidance on structure and content placement within CTD registration submissions.
**Key Responsibilities:**
- Regulatory & Drug Development Expertise:
- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards.
- Partner with CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
- Implement and interpret global regulations and guidance's into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements.
- Lead, Influence, Partner:
- Create an environment within the Global Regulatory Area and across CMC teams that encourages open discussions on issues to achieve a robust outcome on project decisions.
- Leverage internal forums to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
- Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes.
**Requirements:**
- 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.
- Ability to operate and manage operational requirements in a regulated environment.
- Written, spoken and presentation skills.
- Negotiation and influence skills.
- Attention to detail and ability to effectively prioritize.
- Proven effective teamwork skills; able to adapt to diverse interpersonal styles.
We are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.