Our client, in the biotechnology industry, is hiring a VP/SVP, Regulatory Affairs and Quality Assurance.  This role is accountable for playing a vital role in progressing our drug candidates towards U.S. and International approval. The VP/SVP is a highly effective leader and mentor, who leads regulatory affairs and quality assurance to provide high-quality logistical support for our programs.

Responsibilities:

Develop regulatory strategy and global oversight of all regulatory and quality assurance aspects for RAPT programs

• Regulatory Affairs

1. Liaise directly with FDA, notified bodies, and other regulatory agencies
2. Plan and oversee activities in support of INDs, NDAs, MAAs, CTXs, and other
   regulatory submissions
3. Collaborate with senior management and cross-functional project teams to design and implement high-quality regulatory strategies
4. Incorporate a global regulatory strategy into GxP compliance policies, regulatory
   filings, supply chain operations, marketing, sales, and external partnerships
5. Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GXP perspective

• Quality Assurance

1. Provide strategic and technical leadership of Quality Assurance activities and
   deliverables in support of the RAPT product pipeline
2. Collaborate with senior management and all functional groups at all levels of the
   enterprise to drive a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors that support such a culture
3. Help to implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA and EU regulations/directives/requirements and ICH guidelines
4. Work to develop a CMC strategy in the quality function via objectives and plans to ensure quality oversight, timely resolution of issues and early intervention to assure compliance
5. Identify, resolve, or escalate any and all product, process, or customer Quality-related issues that pose risk with respect to the patient, customers, or compliance.
6. Work with and contribute to managing external regulatory- and QA-related CROs and vendors to drive excellence and meet phase-appropriate regulations and timelines

• Leadership and Management
  1. Provide support, mentorship, and guidance to regulatory affairs and quality assurance to ensure staff can independently make sound strategic and tactical decisions
  2. Develop the technical, GMP, and leadership skills of direct reports, including
     performance reviews
  3. Develop processes and infrastructure that support program needs, including but not limited to SOP development and training.
  4. Develop and manage departmental and study-specific budgets

     
     Minimum Qualifications

• Bachelor’s degree in an engineering, science, or related discipline with a minimum of 10 years of direct regulatory affairs and quality assurance experience in the biotech/pharmaceutical industry; advanced degree is a plus (e.g. Ph.D., MS in life science, or MBA)
• Expert knowledge of domestic and international GXP regulations and guidelines, and of industry best practices and standards in regulatory affairs and quality assurance
• Proven NDA track record and commercial support experience
• Significant experience leading face-to-face and other formal interactions with senior regulatory agency representatives
• Solid experience with CMC, clinical and non-clinical development, and Regulatory submissions
• Ability to interact effectively across all levels of the organization; integrates functional expertise with business knowledge to solve problems, and meet priorities and deadlines in alignment with corporate goals and objectives
• Recognized as an influential leader who possesses a cross-functional collaborative skill set
• Demonstrated proficiency in departmental budgeting, organizing, and planning
• Demonstrated ability to work both independently and in a team environment
• Excellent oral and written communication skills with strong attention to detail and the ability to coordinate and oversee multiple activities

Preferred Qualifications

• Experience in interactions with the Oncology, Dermatology, and/or Allergy/Pulmonology divisions of FDA, including regulatory authority inspections (e.g. pre-approval inspections)
• Experience with small molecule development
• Significant, multinational Phase 1-4 experience
• Experience with multi-national development partners