Senior Associate, Regulatory Affairs, Clinical and Nonclinical

The Opportunity

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.


RESPONSIBILITIES

  • 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
Details

We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.

Our Client

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

Skills:

  • 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.

Education:

  • 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.

Not exactly? Join Our Talent Community, and we'll let you know of additional opportunities.

EASY APPLY

Optional. 20 MB file size limit. Supported file types.

Upload your Resume
I have read and accepted the Terms & Privacy Policy