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Senior Regulatory Affairs Consultant - Vaccines

求人ID 63352BR ロケーション アメリカ合衆国 仕事内容
Amazing opportunity to join Parexel's Consulting team as a Senior Consultant and partner with a dedicated client with an extensive and interesting product portfolio!

PRIMARY DUTIES AND RESPONSIBILITIES:
  • Authoring of pre-IND meeting request letters, Briefing Dossiers and INDs (Module 3, Module 2.3)
  • Provide submission (pre- and post-approval) strategies for small molecules and biologics
  • Preparation, review and editing of CMC regulatory submissions (CTD Modules 2 and 3) for US FDA and Health Canada
  • Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
  • Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
  • Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Generally strong leader who is effective manager and is able to bring working teams together for common objectives, people management experience preferred.
  • Assisting in Regulatory Agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
  • Implementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications.
  • Communicating with Agencies and attending Agency meetings as needed to assist the global liaison.
  • Participating as an active member on the global regulatory team. He/she will attend cross-functional meetings as required, in collaboration with, and to assist the global liaison.
  • Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global liaison in authoring of regulatory strategy documents.

Qualifications

Minimum of a Bachelor’s Degree, Advanced Degree preferable in Biochemistry, Biotechnology, Molecular- or Cell Biology, or have comparable experience in research
Several years experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs.
Knowledge in molecular and cell biology
A deep understanding of molecular biological and (bio-)chemical methods
Extensive experience in preparing documentation for regulatory authorities.
Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus; however, those with a strong knowledge of FDA, EU, Canada, Japan, and ROW regulatory knowledge will also be considered.
Previous post-marketing exp is a plus

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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