Analyst, Regulatory Affairs

San Rafael, CA 94901

Posted: 06/18/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 6412

Duties: 

Support the Global Regulatory Policy Team in the following regulatory policy activities:
  • Review and inform on recently published global regulatory legislation and policies impacting development of treatments for rare diseases.
  • Provide project management support to the policy team in generation of comments on draft guidances
  • Track Team memberships and involvement in policy trade associations and organizations
  • Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.
  • Lead certain policy cross-functional meetings including minutes and action items
  • Provide strategic logistical support for managing policy calendars and deliverables.
  • Develop and manage internal policy publications.
  • Develop and manage dashboards for policy team initiatives
  • Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
  • Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.

 

Skills:    
  • Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs and/or policy
  • Strong verbal and written communication skills
  • Strong project management skills
  • Proficient with computer and standard software programs
  • Organizational skills
  • Communication skills, excellent verbal, written and presentation skills
  • Very strong attention-to-detail

 

Education:          
  • 5 + Years of Experience
  • Bachelors or Masters Degree in biology or other life sciences discipline

Skills:    

  • Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs and/or policy
  • Strong verbal and written communication skills
  • Strong project management skills
  • Proficient with computer and standard software programs
  • Organizational skills
  • Communication skills, excellent verbal, written and presentation skills
  • Very strong attention-to-detail

 

Education:          

  • 5 + Years of Experience
  • Bachelors or Masters Degree in biology or other life sciences discipline
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