Job Description Senior Regulatory Affairs Associate Reporting to the by queenvikki


									                                                                   Job Description
                                                Senior Regulatory Affairs Associate

Reporting to the Manager, Global Regulatory Affairs, this position requires hands-on preparation
of all aspects of regulatory submissions.

  Prepare and file drug product submissions for the US, Canada, EU and international agencies
  (e.g. INDs, CTAs, CTs, NDAs, NDSs NCs, supplements/variations)
  Assisting with the planning, coordinating and execution of meetings with world-wide regulatory
  Review technical reports and summary documents (clinical, pharmacology & toxicology,
  chemistry & manufacturing) for adherence to regulatory guidelines, strategies and commitments;
  evaluate scientific data and identify potential issues/challenges
  Maintenance of drug product registrations for the US, Canada, Europe and other International
  regulatory agencies, as assigned
• Preparation and maintenance of Regulatory Affairs Departmental SOPs and provide
  regulatory review of SOPs from other departments, as necessary
• Monitor and maintenance of agency guidelines and Internet updates for US (FDA), Canada
  (HPFB), UK (MHRA), EU (EMEA) and ICH.
• Assist the department in responding to internal requests for regulatory information; assist in
  the retrieval of these materials from the internet, regulatory authority or other source of
  information and assist in the dissemination of information to appropriate Nuvo personnel
• Review internal and external documentation for adherence to regulatory guidelines, including
  but not limited to protocols and study reports (Quality, Nonclinical, Clinical), Investigator
  Brochures, labelling, master batch records and specifications

• Undergraduate degree in science, health science, pharmacy or nursing
• Minimum 5 years experience in Regulatory Affairs
• Good knowledge and understanding of Regulatory Agency regulations and guidelines, with
  the ability to interpret and apply them. Experience with U.S., Canadian and European
  regulations preferred.
• Excellent oral and written communication skills
• Proven Project Management and time management skills
• Computer proficiency with MS Word, Excel, Access, PowerPoint, Project, Adobe;
  knowledge of electronic regulatory publishing processes preferred

Please submit your resume by email to          Only those selected for an
interview will be contacted.

Rev. 004—April 28, 2008                                                               Page 1 of 1

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