Vice President of Regulatory Affairs

Company: Cymabay Therapeutics Inc.
Location: Newark
Posted on: January 12, 2021

Job Description:

Reporting to the Chief Regulatory Officer, the Vice President of Regulatory Affairs will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions. In conjunction with the Chief Regulatory Officer, s/he will be responsible for devising and implementing global regulatory strategy and providing leadership oversight for all regulatory submissions, regulatory compliance, regulatory advice and counseling in all areas of development, and commercial regulatory activities across the lifecycle of products for responsible territories. In addition, the ability to facilitate strong coordination and collaboration across internal departments and stakeholders. Essential Functions and Job Responsibilities:

• Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions
• Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals
• Provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and execution
• Provide direct regulatory oversight to all applicable clinical and CMC activities (development and commercial)
• Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Company personnel and assist as a liaison between the Company and regulatory authorities
• Keep peers and superiors apprised of expected changes to the regulatory landscape affecting CymaBay products
• Lead the compilation, review, and submission of all INDs/CTAs, marketing applications and/or post approval amendments
• Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction
• Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure
• Ability to travel up to 10% Minimum Qualifications:
  • BS degree with a focus in life sciences or related; an advanced degree is preferred
  • Minimum 15 years of experience Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience
  • Experience leading, designing, writing, and submission of regulatory filings and NDA/MAA filing experience, is required
  • Experience leading the submission process for both new entities and line extensions of existing products
  • Experience supporting commercialization and post-marketing activities and requirements for approved products is a plus
  • Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development, and post-marketing activities
  • Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA
  • In-depth understanding of the drug development, product commercialization and life cycle management processes combined with experience in Quality Assurance, Development, Clinical and Compliance is desired
  • Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups
  • Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards How did you hear about our company and this job opening? Are you legally authorized to work in the United States?* Will you now or in the future require sponsorship for employment visa status? (e.g., H-1B visa status?* Are you able to perform the essential job functions of the job for which you are applying, either with or without reasonable accommodation?* If no, describe the functions that cannot be performed. If hired, what date can you start work?*

Keywords: Cymabay Therapeutics Inc., Newark , Vice President of Regulatory Affairs, Executive , Newark, New Jersey