Senior Manager, Regulatory Affairs

Menlo Park, CA 94025

Posted: 09/25/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16465

Senior Manager, Regulatory Affairs

Menlo Park, CA

SENIOR MANAGER, REGULATORY AFFAIRS:


The Senior Manager will develop and implement regulatory strategies in support of various clinical,
non-clinical and CMC disciplines to support the development of our products
candidates. This role requires some leadership in planning and coordinating the development and
execution of regulatory submissions to support the clinical development programs.


ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Responsible for specified regulatory deliverables, working with the VP of Regulatory and cross functional
  • stakeholders, as needed.
  • Lead the preparation, review, assembly and submission of regulatory documentation such as
  • INDs, other regulatory equivalents, s annual reports, and other submissions, as assigned by
  • management
  • Represent Regulatory Affairs on cross-functional teams, such as the project team(s), study
  • management team(s), project team(s), as appropriate
  • Develop, drive, and coordinate regulatory timelines (internal and external), working closely with
  • the VP Regulatory Affairs and other key stakeholders
  • Provide regulatory guidance to teams (on content, messaging & alignment), as appropriate, with
  • support of the VP of Regulatory
  • Manage the internal review and approval process for submissions and regulatory questions and
  • responses; Ensure compliance of regulatory strategies and submissions with current regulations
  • and guidance
  • Manage internal meetings around regulatory submissions and maintain internal trackers and
  • databases, as appropriate
  • Must have knowledge of regulatory requirements, including ICH requirements and an
  • understanding of current global and regional trends in Regulatory Affairs
  • Excellent organization skills and ability to work on and /or oversee a number of projects with tight
  • timelines; Strong project management abilities
  • Excellent verbal and written communication skills and interpersonal skills, is required
  • Experience with Microsoft Office (MSWord, PowerPoint, Excel, Project)
  • Having an eye for detail and ability to multi-task effectively are required
  • Contribute to the continuous improvement of existing department processes and strategies,
  • providing recommendations in area of expertise
  • Works on special projects, as requested
  • Must be willing to work in a smaller organization and support other duties, as assigned
  • Work is performed under minimal direction from a senior Regulatory Affairs professional


EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • BS Degree in the scientific field is required; an advanced degree (Masters, PharmD, PhD) is an
  • added bonus
  • Minimum 7 years of experience in Regulatory Affairs
  • Regulatory knowledge and experience in gene therapy highly desirable
  • Comprehensive knowledge of applicable regulations
  • Experience in eCTD format and structure; Knowledge of both GCP and GMP regulations
  • Capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents
  • related to drug development
  • Capable of leading significant general projects for the function

 

Felicia Id-Deen

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