Associate, Regulatory Affairs CMC III

San Rafael, CA 94949

Posted: 04/10/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 15473

Bayside Solutions is seeking an Associate, Regulatory Affairs CMC III to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.

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. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

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.

Associate, Regulatory Affairs CMC III

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • 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:
  • Coordinating the planning, preparation and submission of global regulatory CMC-related submissions for clinical and commercial products such as: post approval variations, Marketing Application(s), Annual Reports, Clinical Trial Applications, and amendments.
  • Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
  • Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time.
  • Performing regulatory research and drafting reports summarizing regulatory requirements.
  • Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
  • Ensuring consistent and appropriate communication within the department and with other functional areas.
  • Interfacing with global Regulatory partners, internal cross functional teams, and consultants.
  • Attending relevant functional area and project team meetings.
  • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

Summary of Qualifications:
  • BA/BS degree in life sciences, chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
  • 5+  years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global pharmaceutical and/or Biotechnology Company (preferably with exposure to biologic products).
  • Thorough understanding of relevant drug development regulations and guidelines (ie, FDA regulations and ICH guidelines) as well as an understanding of CGMP.
  • Outstanding interpersonal and communication (written and verbal) skills is required.
  • Strong writing and editing skills for technical documentation.
  • Experience with devices or combination products a plus (ie, HFA evaluations, FMEAs).
  • Effective task planning and coordination abilities.
  • Proficient with computer and standard software programs.

Ethan Christenson
Scientific Recruiter

If you are looking for career growth or new opportunities you have come to the right place! Here at Bayside solutions we specialize in relationship based recruiting, we are focused and determined to take your career in the direction you want it to go. I would love to talk to you about your career objectives, sports, traveling, or anything else that interests you. I look forward to getting to know you and where you want to go!
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