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Manager Regulatory Affairs - United States  

Company managed [?] Still accepting applications

Posted on : 08 May 2017

Project Description

This Regulatory Affairs (RA) position is responsible for the regulatory support of projects through product development, registration processes and life-cycle management as well as participation in multidisciplinary regulatory project teams.

  • Registration Applications (Marketing Authorisation Applications, Clinical Trial Applications): Compilation, submission and processing of registration applications for designated projects 
  • Ensure that these registration applications are correct and complete and submitted in due time to the competent regulatory agency consistent with the company's strategic goals for manufacturing and marketing. 
  • Timely coordination/compilation/drafting of eCTD ready regulatory documents (e.g. Health Authority Briefing Books, Clinical Trial Applications (CTAs), International Registration Dossiers, Target Product Profile (TPP), Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), Investigator’s Brochure, Development Safety Update Reports (DSUR)) 
  • Regulatory Life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports) 
  • Primary interface with NIH OBA and responsible for coordination/compilation/drafting/submission of OBA required documents (e.g. safety reports, DSUR) 
  • Coordination/compilation/drafting of briefing packages for meetings with regulatory agencies, e.g. EoP2 and pre submission agency meetings with a main focus on US and EU regulatory aspects of scientific advice and market application processes 
  • Establish effective working relationships with internal and external customers, as well as Regulatory Agencies 
  • Coordinate the Health Authority response team through the regulatory approval process 
  • Inform regulatory authorities without delay of reported adverse reactions/side-effects pre- or post-approval in cooperation with drug safety. 
  • Represent line function as a member of a Project Team, for one or more development projects and assure RA input (by consulting with other RA members as necessary) into project teams for designated projects 
  • Preparation of periodic (monthly) status reports on the regulatory aspects of the designated projects, as necessary 
  • Review of quality, pre-clinical and clinical documents for scientific plausability, accurateness and regulatory compliance 
  • Maintain up to date knowledge of regulatory requirements and communicate updates as appropriate 
  • Regulatory approval of clinical trial labelling 
  • Secondary contact for all US FDA submissions 

Your qualifications 
  • University degree (MSc) in life-science (e.g. biology, molecular biology, biochemistry, pharmacy etc.) and/or PhD 
  • At least 5 years of experience in regulatory activities in drug development 
  • Advanced knowledge of regulatory submission and approval processes 
  • Involvement in IND/CTA submission and approval 
  • Familiar with at least one major Health Authorities (i.e. Europe, USA, Canada) 
  • Experience in the development and registration of biologics 
  • Excellent written and verbal communication skills 
  • Fluency in English verbally and in writing 
  • Decision making ability within the scope of the job description 
  • High level of computer knowledge and skills 
  • Detail oriented at read out of scientific data for integration into regulatory documents 
  • Experience with oncology therapeutic area and knowledge of immunotherapy and/or vaccine products highly desired