Director / Sr. Director, Regulatory Affairs

Menlo Park, CA 94025

Posted: 09/24/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16461

 

 

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
  • Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions
  • Use extensive knowledge of US, EU, and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development programs and regulatory issues to support corporate goals
  • Provide direction for effective execution of the developed regulatory strategies, tactics and implementation of all regulatory aspects of assigned program, and responsible for the timely development and submission of regulatory documentation
  • Provide guidance on content and provide review and approval of regulatory submissions including requests for Designation, Meeting Background Packages, INDs and CTAs
  • Build partnerships within a matrixed team-oriented structure with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resource(s)
  • Work in collaboration with the Vice President of RA, to inform/advise on the gene therapy program requirements and timelines to support corporate goals
  • Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedence.

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
  • Must be willing to work in a smaller organization and support other duties, as assigned
  • Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization
  • Strong organizational, communication, negotiation and interpersonal skills is required
  • Having an eye for detail is required and ability to multi-task effectively
  • Work on special projects, as requested
  • Exhibit strong organizational leadership and values to influence the success of the Regulatory group.

 

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • BS Degree is required; an advanced degree (Masters, PharmD, PhD) is an added bonus
  • Minimum 12 years experience in Regulatory Affairs
  • Expert knowledge and experience in gene therapy highly desirable
  • Specialty pharmaceuticals or rare & orphan disease experience are both beneficial
  • Experience as lead regulatory strategist
  • Comprehensive knowledge of applicable regulations
  • Experience in requirements for IND/CTA, BLA/MAA, product lifecycle management, interactions with Health Authorities
  • Experience interacting with external business partners and Health Authorities
  • Proven ability to work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism
  • Business travel up to 10-15% travel.

Stephanie Harris

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