Regulatory International Project Manager

San Rafael, CA 94901

Posted: 09/12/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 16414

Bayside Solutions is seeking a Regulatory International Project Manager 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.

Regulatory International Project Manager

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:
  • Manage Regulatory International operations including scheduling and facilitating meetings with Regulatory International team members and Global Regulatory team members (schedule, prepare/distribute documentation and ensure action item follow-up).
  • Create and maintain Regulatory International timelines for new Marketing Applications and lifecycle management activities, and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.
  • Liaise with Regulatory Project Managers and Global Regulatory team members to ensure timelines are integrated to reflect cross-functional dependencies
  • Create and maintain reporting dashboards for teams and management.
  • Monitor submission preparation progress to ensure timely filing to health authorities.
  • Document project milestones/deliverables and report progress against team, department, and corporate goals.
  • Facilitate short and long-term planning activities.
  • Maintain product registration tracking information for assigned projects in collaboration with Regulatory Project Managers.
  • Establish personal operational objectives and independently manage workday to ensure they are achieved.

Summary of Qualifications:
  • Bachelor’ s degree required.
  • Project Management Professional and/or Regulatory Affairs Certification a plus.
  • Minimum 3 years of experience in a project management or scheduling environment
  • Ability to successfully manage multiple projects to deadlines.
  • Knowledge of Regulatory Affairs submissions and nomenclature desirable.
  • Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology.
  • Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.
  • The candidate should possess the ability to work as part of an interdisciplinary team, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.

Allison Glogovac

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