Top tier growing Global Pharmaceutical company is looking for a vibrant and sharp Manager of Regulatory Affairs to join their dynamic Team
The is company has been named top new Pharma and one of the Best Employers in 2017
The role canbe in EITHER their Seattle, WA HQ or their NEW offices in San Francisco (full relocation package offered- And great benefits too)
Must be a self starter with initiative and Regulatory Affairs experience in the Pharma industry- must have Regulatory affairs and CMC and Reg Startegy experience
BLA experience is strongly desired
This group is made up of highly intelligent, sharp communicators- looking for someone to join them as they grow!
Regulatory Affairs Manager
Regulatory Affairs Seattle, Washington (or secondary option is SF, CA)
We are a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.
The primary focus of the Manager Regulatory Affairs role will be to provide support for the regulatory affairs department with products in mid-to-late clinical development.
The incumbent will closely interact with multiple functions to create high quality regulatory submissions that support Juno’s product development strategy. The ideal candidate is someone who is comfortable with a fast-paced work environment with other high performers. This person should be an innovative thinker, good problem solver and someone looking to expand their limits. Key activities include (or may include):
Providing input to regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in accordance with regulatory agency requirements, standards, and corporate practices
Provide regulatory expertise and guidance to cross functional teams on regulatory requirements for global development and market registrations.
Experience with clinical trial (IND) and marketing applications (BLA/NDA) filing requirements including content requirement, technical writing, and tracking timelines. Ensure the development of high quality submissions.
Staying abreast of and reporting on emerging regulatory intelligence and/or activities, such as new/revised regulations and regulatory guidances, competitive product applications, designations and/or approvals, and advisory committee meetings and their outcomes
Representing the regulatory affairs function in project teams to provide regulatory support and advice
Interacting with corporate partners regarding various regulatory matters
Providing support for regulatory interactions, including meetings and teleconferences
Drafting and/or modification of applicable SOPs and/or other written practices relating to the regulatory affairs function
Shows good judgment to determine when to escalate problems to his/her superior.
Bachelor’s degree (or equivalent) in a science-related discipline (e.g., biology, chemistry, microbiology, immunology).
7+ years’ experience in a regulated industry
5 years’ experience in regulatory affairs
Strong working knowledge of U.S. regulatory requirements for biologics, especially cell and/or gene therapy products
Excellent written and oral communication capabilities, with particular attention to detail
Highly organized, independent, and self-motivated with ability to multi-task
Strong time and project management competency, with the ability to meet deadlines
Experience with eCTD – electronic documents and submissions.
Demonstrated ability to work within a cross-functional team and in a matrix environment.
Experience with NIH Appendix M submissions
Experience with ex-U.S. regulatory submissions
High degree of proficiency with MS Office applications (including MS Word, MS Visio, MS Powerpoint) and Adobe Acrobat
Our headquarters, situated in the bustling South Lake Union district of Seattle, sits among some of the most visible organizations in the world. Seattle offers award-winning restaurants, a vibrant, hip music scene and spectacular views of water and mountains. Within an hour’s drive of Seattle, you can be fishing, skiing, hiking or tasting world-class Washington wines. We have a NEW location in San FRANCISCO, ca AS WELL- THE HUB OF THE STRONGEST Biotechs and pharma