Lilly Regulatory Affairs Associate - Maternity Leave in United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly is one of the top 10 largest pharmaceutical companies in the world. Lilly has remained dedicated to creating medicines that help improve peoples' quality of life for more than 145 years. At the heart of Lilly's operations are its core values – excellence, integrity and respect for people and these are reflected in business practices that include strong governance principles, the ethical development of medicines, transparency and ethical product promotion.
- Review and Approval of Canadian promotional and non-promotional materials. Specific responsibilities/details include but are not limited to:
Develop relationships with personnel in other Lilly functional areas (i.e., marketing, medical, legal, labeling, compliance, quality etc.) to effectively implement appropriate promotional and medical messages.
Maintain understanding of the Canadian advertising and promotional environment
- Obtain timely clearance of clinical trial applications (CTA’s) for new research compounds to facilitate clinical trials in Canada through the co-ordination of regulatory CTA submissions and maintenance.
Develops submission strategies for CTAs
Determines resource needs
Organizes and co-ordinates necessary meetings
Manages preparation of submissions
Identifies potential review issues and implements action plans to address
Assesses when external consultants are necessary
Ensures submission content meets requirements
Determines submission requirements for changes
- Communication with the Health Product Food Branch (HPFB)
Responds to requests for additional information pertaining to CTA submissions under review as required
Prepares briefing packages for pre-submission CTA consultation meetings
Prepares draft meeting minutes and ensures appropriate follow-up
Develops and uses network of contacts to gather information (e.g. clarify interpretation of regulations, policies and/or guidelines)
Develops and implements strategies for issuing safety communications (DHPL, NtoH, PA, etc.), as needed
Responds and coordinates responses to requests related to CTs including but not limited to DSURs, ad hoc requests, etc.
Develops effective working relationships with HPFB to help influence and expedite positive decisions on CTAs.
- Other reporting responsibilities:
- Supports regulatory operations such as filing of the Annual DIN Notification and Medical Device License, and other projects as required
- Standards and Inspection Readiness
Supports the development of local and global SOPs to ensure alignment with local laws and regulations, as needed
Helps to interpret relevant regulations and guidelines and acts as a contact person in the Canadian affiliate(s)
Basic Requirements: Education and Experience
University degree in a relevant scientific field (e.g. pharmacology, pharmacy, toxicology, nursing, etc) and/or post-graduate diploma course in Regulatory Affairs
Minimum of 3 years regulatory experience within a pharmaceutical company or any other relevant experience
Excellent communication (written and verbal), interpersonal, organizational and negotiation skills
Strong knowledge of quality systems
Project management experience
Eli Lilly Canada is committed to employment equity. We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!