Director, Commercial Regulatory Affairs

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Company

QED Therapeutics

Location

San Francisco, California

Who You Are

Reporting to Vice President of Regulatory Affairs, this position is responsible for developing, executing and providing guidance for effective, proactive commercial regulatory strategies and plans. Key responsibilities include establishing and improving review policies, as applicable, oversight of review of promotional and training (“commercial”) material and medical material, as well as developing strategies and timelines, conducting relevant health authority meetings, acting as liaison with Food and Drug Administration’s Office of Prescriptive Drug Promotion (OPDP), and contributing to assessment of corporate risk tolerance.  This involves working closely with other functions, including Medical Affairs, Marketing, Legal and Sales team members.

Responsibilities

  • Develop, execute and provide guidance for effective, proactive commercial regulatory strategies and plans
  • Manage the regulatory aspects of promotional materials, as well as sales training materials and medical materials
  • Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials, based on FDA and international regulatory requirements
  • Provide interpretive analyses of regulatory guidance documents, regulations, directives, or enforcement actions that impact the Company’s promotion of products and operations; advise cross functional team members regarding their applicability and impact
  • Ensure high-quality and timely regulatory submissions, as applicable, in compliance with all applicable  regulatory requirements, and in alignment with corporate goals
  • Act as the primary liaison between QED and OPDP
  • Interface with other team leaders to ensure coordination and implementation of consistent standards and processes, as well as development of core promotional messaging in support of launch
  • Co-chair PRC and review PRC material (or oversee delegate)
  • Update and provide appropriate promotional compliance and regulatory training and education to sales reps, medical science liaisons, and contracted staff regarding their respective roles and responsibilities
  • Analyze and communicate current OPDP regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Requirements

  • BA/BS degree; advanced degree preferred
  • Industry-related regulatory experience in Pharmaceuticals, Biopharmaceuticals or Biotechnology industry, large and small, with a minimum of 5 years in regulatory affairs
  • Experience leading one or more product launches and overseeing PRC
  • Minimum requirements are flexible, but 10 years minimum industry experience is generally required
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices; ability to interpret and apply regulations
  • Experience with electronic submission requirements and review of promotional materials prepared for support of regulatory filings
  • Proven ability to think strategically
  • Proficient in written and oral communications in English, including presentation and interpersonal skills
  • Ability to work in close collaboration with colleagues in regulatory department and cross-functionally
  • High attention to detail; ability to organize, prioritize, and delegate assigned projects
  • Accountable for results and goal attainment
  • Ability to work independently with limited supervision, adapt to change and manage multiple tasks
  • Ability to problem solve and make decisions on complex issues, often in a cross-functional team setting
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools (Veeva) desirable

What We Offer

Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts.

A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts; and let science speak.

Learning and development training to help employees be the best version of themselves. 

Collaborative business environment.

Excellent compensation package (Base, Performance Bonus, Stock, RSU programs).

Excellent benefits package.  

Flexible PTO.

With office locations in San Francisco, Boston, New York and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs.

Fast-paced, data-driven, work environment with world-class R&D minds and capabilities.

Work with the most productive groups of R&D operators in the industry.

Partnerships with leading institutions.A platform for meaningful scientific contributions to shine.

Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead and supported in their efforts to do so.

About QED

With singular focus, QED is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders.

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Director, Commercial Regulatory Affairs

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