Associate, Regulatory Affairs CMC III

San Rafael, CA 94949

Posted: 11/12/2018 Employment Type: Contract Industry: Clinical & Scientific Job Number: 14175

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:
  • This position focuses on the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs.
  • The role involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings.
  • Expertise with biologics and/or drug/biologic/device products is strongly preferred.  This position is also responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments.
  • Oversee planning, preparation, and submission of the CMC sections of marketing applications globally.
  • Ensure that the sections are accurate, complete, well-written, and meet all relevant country-specific requirements.
  • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners.
  • Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.

Summary of Qualifications:
  • 5+ Years’ Experience with Bachelor’ s degree in chemistry, biology, biochemistry or related field.
  • Strong communication and management skills are required.
  • Excellent organization skills.
  • Attention to detail is a must.
  • Understanding of ICH guidance and CMC regulations.

Erik Cordova

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