Job Description Senior Regulatory Affairs Associate Reporting to the by queenvikki

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									                                                                   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.

KEY RESPONSIBILITIES:
  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
  agencies
  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

REQUIRED QUALIFICATIONS & SKILLS:
• 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 hr@nuvoresearch.com.          Only those selected for an
interview will be contacted.




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

								
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