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Regulatory Affairs Associate

Cambridge, MA

Posted: 03/12/2019 Job Category: Clinical: Regulatory Job Number: 2302

Our client is looking to add a Regulatory Affairs Associate to their team on a contract basis. The position provides regulatory affairs support for the Regulatory Affairs organization, including preparation and management for routine regulatory submissions in the Regulatory Strategy group, and support and coordination for multiple assigned initiatives, projects and activities such as contract management, budget preparation and tracking, and complex meeting management. This role will also provide focused or tactical support for the Head of Regulatory, including coordination of strategic regulatory meetings, licensing, contractor management and travel support, as needed.

JOB RESPONSIBILITIES:

Regulatory Associate (75%):
  • Prepare regulatory documents for routine submission
  • Draft Agency submission cover letters, as requested
  • Organize and manage investigator submissions, as requested
  • Health Authority Communication Management - Upload, track, and provide reports for communications and commitments from Health Authorities as requested

Regulatory Department Coordinator (25%):
  • Contract Management & Budget preparation and management
  • Complex meeting & travel support (e.g. FDA Meetings)
  • Other tasks as assigned

REQUIREMENTS/QUALIFICATIONS:
  • Bachelor’ s degree with 2 years of relevant experience in a regulated environment or Associate degree and 5 years of coordinator/ administrative experience, in a similar, fast paced environment
  • Desire to learn Pharmaceutical Regulatory Affairs
  • Excellent written, verbal, and interpersonal communication skills
  • Strong computer skills in Word, Excel, PowerPoint, Outlook
  • Proactive, detail oriented, able to multi-task
  • Excellent time management and ability to prioritize work and meet deadlines
  • Experience working in a cross-functional environment
  • Familiarity with SharePoint (Office 365), SAP, Concur, Veeva, ARIM a plus
  • Experience in the Biopharma/ Pharmaceutical - preparing and supporting regulatory lead in development preferred

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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