We're looking for a **Senior Associate, Regulatory Affairs,
Clinical and Nonclinical** , working in the **Healthcare Systems &
Services** industry in **San Rafael, California** .
+ 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
+ Supports the preparation and filing of INDs and CTAs
+ Supports multiple projects if necessary
+ Other duties as assigned
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
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
+ Proven ability to manage critical projects with a minimum of
+ Prior experience compiling filings for FDA submissions is
required with the ability to successfully manage projects to
+ Prior experience in a product development role
+ Proficient with computer and standard software programs
+ Strong interpersonal and communication (written and verbal)
+ Effective task planning and coordination abilities
+ Demonstrated good judgment
+ Capable of working with an interdisciplinary team
+ Strong understanding of US FDA regulations applicable to
+ Prior experience preparing ex-US CTAs.
+ Prior experience with orphan products.
+ BS degree (advanced degree desirable) in life sciences or
We are offering Competitive Compensation and Benefits. This
position may present an opportunity to go permanent.
**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 .
Not exactly? Join Our Talent Community
(https://jobs.psgglobalsolutions.com/register) , and we'll let you
know of additional opportunities.
EOE Protected Veterans/Disability