Regulatory Affairs Associate II

Novato, CA | Contract

Post Date: 09/11/2017 Job ID: 11918 Industry: Clinical & Scientific

Bayside Solutions is seeking a Regulatory Affairs Associate II to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.  

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Regulatory Affairs Associate II

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.  
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • Assemble FDA and ex-US  regulatory filings and briefing books, leveraging subject matter experts. 
  • Work with supervisors and vendors to plan filing schedules
  • Work with publishing group to plan and finalize submissions
  • Research regulatory requirements

Required Qualifications:
  • BS in life sciences or equivalent
  • Minimum of 2  years experience in Regulatory Affairs in the biotechnology industry
  • Prior experience managing ex-US regulatory filings and associated vendors/CROs is required
  • Prior experience reviewing Informed Consent Forms, Reviewing drug shipment packages, and eTMF filing highly desireable
  • Prior experience compiling filings for FDA submissions is highly desireable
  • Proficient with computer and standard software programs
  • Strong interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • Capable of working with an interdisciplinary team

 

Aqsa Khan

If you are interested in taking the next step in your career, Bayside Solutions is the right place. As a scientific recruiter at Bayside, I take pride in building strong relationships with my candidates as I help them find their dream job. Whether it is resume advice, career choices, or job opportunities, I am just a phone call away. I hope I get the pleasure to learn more about you and the opportunities that interest you.

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