Director, Regulatory Affairs

Company: Brightleaf Group
Location: Irvine
Posted on: April 9, 2021

Job Description:

Director, Regulatory Affairs--(Science & Biotech) Irvine, CA 92614
Recruited by: Sheryl Horowitz - Recruiter - F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

• Industry: --Science & Biotech
• Expires: --May 02, 2021 Share this job: Please ensure all fields are filled in and your resume is attached Resume:
  OR Submit your information and resume instantly with Monster! Job Description Overall Purpose:
  
  Reporting into the VP of Regulatory Affairs, the Director of Regulatory Affairs and Pharmacovigilance is responsible for the creation, revision and review of various documents associated with clinical research. The documents may be submitted to Health Authorities worldwide to support clinical development and registration of our client's ophthalmic drug candidates. This position is also responsible for overseeing post marketing pharmacovigilance and promotional activities. Furthermore, the incumbent will demonstrate strong agility to change, and leadership to mentor, coach and inspire others in manner that will positively contribute to the successful execution of Regulatory and Pharmacovigilance strategy.
  
  Essential Duties and Responsibilities:
  
  Primary Responsibilities
  --- Perform medical/regulatory writing activities that support the preparation of regulatory and clinical documents required to support global drug development and registration activities (N.A., EU and Japan)
  --- Serve as regulatory affairs representative on assigned product teams and closely collaborate with personnel from clinical and scientific departments
  --- Assist in writing, editing and reviewing of diverse regulatory and clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, clinical data summaries, and other medical/regulatory documents, including regulatory summary documents (e.g., ISE/ISS reports) and clinical labeling sections
  --- Develop, implement and manage content templates and documentation format required for standardization of regulatory and clinical documentation to support the company's development and registration activities
  --- Coordinate and conduct interdepartmental review and sign-off document deliverables according to procedures
  --- Oversee post-marketing pharmacovigilance system and procedures and preparation and submission of the post-marketing pharmacovigilance reports as required
  --- Oversees IND clinical amendments, including expedited safety reporting
  --- Oversees the pre- and post-marketing promotional activities
  --- Reviews safety management plans for clinical trials
  --- Works on Advisory Committee presentations
  --- Handles various types of regulatory submissions with minimal oversight
  
  
  Qualification Requirements:
  
  Education & Experience
  
  Bachelors or advanced degree (MS, PhD or MD) in Life Sciences/Health-Related Sciences with at least 5-10 years of regulatory affairs & post-marketing pharmacovigilance experience in a pharmaceutical or biotechnology company, preferably in the ophthalmic therapeutic area. Experience with review of post-marketing promotional materials and filing requirements, a plus
  
  Knowledge & Abilities
  
  --- Knowledge of global regulatory publication guidelines (FDA, EMA, ICH, etc.) and best practices
  --- Proficient in pertinent software, such as Microsoft Office Suite and bibliographic software
  --- Knowledgeable in international dossier preparation (e.g., IND/CTA/NDA/MAA/NDS), including electronic document submissions (i.e., etc.)
  --- Excellent written/oral communication skills
  --- Ability to lead through ambiguity, inspire and motivate team
  --- Agile in ability to identify opportunities for and lead through change
  --- Clear, transparent, and inspiring communicator, able to achieve through others
  --- Demonstrate leadership behaviors that inspire others
  --- Coach and mentor to team members
  --- Ability to understand and interpret data/information and its practical application
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Keywords: Brightleaf Group, Irvine , Director, Regulatory Affairs, Executive , Irvine, California