We are looking for a Senior Associate, Regulatory Affairs, Clinical and Nonclinical, working in the Healthcare Systems & Services industry in San Rafael, California, United States.
Prepares, submits, and maintains domestic and international regulatory filings, both pre and post approval
Attends project team meetings across functional areas
Coordinates meetings with regulatory authorities
Assist with development strategy
Supports the filing, review, and approval of global license applications
Supports the preparation and filing of INDs and CTAs
Supports multiple projects if necessary
Other duties as assigned
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
At least 2-4 years of experience in Regulatory Affairs in the biotechnology industry
Proven ability to manage critical projects with a minimum of supervision
Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines
Prior experience in a product development role
Proficient with computer and standard software programs
Strong interpersonal and communication (written and verbal) skills
Effective task planning and coordination abilities
Demonstrated good judgment
Capable of working with an interdisciplinary team
Strong understanding of US FDA regulations applicable to therapeutic products.
Prior experience preparing ex-US CTAs.
Prior experience with orphan products.
BS degree (advanced degree desirable) in life sciences or equivalent.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.