Vice President Regulatory Affairs - Meet

We are excited to partner with a rapidly growing biotech company that is pioneering the development of novel therapies. With a strong financial foundation and a pipeline of innovative clinical-stage programs, this organization is poised to make significant contributions to the healthcare space. They are looking to expand their executive team with a highly skilled and strategic Vice President of Regulatory Affairs to lead regulatory initiatives and drive the company’s mission forward.

Position Overview:

As the Vice President of Regulatory Affairs, you will be responsible for overseeing all regulatory functions across the company’s pipeline, from early-stage development through commercial launch. You will provide strategic leadership and direction to ensure successful interactions with regulatory agencies and ensure timely and efficient regulatory submissions. This role requires someone with deep expertise in navigating complex regulatory environments, particularly in the biotechnology sector, and the ability to work closely with executive leadership and cross-functional teams to drive business success.

Key Responsibilities:

• Lead the creation of global regulatory strategies for pipeline programs in collaboration with senior leadership, clinical, and preclinical teams. Ensure alignment with business objectives while meeting all regulatory requirements.
• Direct the preparation and submission of high-priority regulatory filings, including INDs, CTAs, BLAs, and MAAs. Ensure that all submissions meet regulatory requirements and are aligned with project timelines.
• Serve as the principal point of contact with regulatory agencies including the FDA and international health authorities. Cultivate strong relationships with regulatory bodies to facilitate smooth submission processes and discussions.
• Work closely with clinical development, legal, operations, and other departments to provide regulatory guidance throughout the product development lifecycle. Contribute to clinical trial designs, risk management strategies, and product development plans from a regulatory perspective.
• Identify and mitigate regulatory risks and ensure that company objectives are met while adhering to regulatory standards. Provide proactive solutions to address challenges that may arise during development and submission processes.
• Ensure ongoing compliance with regulatory requirements across all global markets, including US, EU, and other regions. Develop and implement regulatory best practices and processes to optimize efficiency and consistency in all regulatory activities.
• Lead, mentor, and build a high-performing regulatory affairs team. Foster a culture of innovation and regulatory excellence while supporting professional growth and development for your team.
• Stay up-to-date with the latest regulatory trends, policies, and guidance. Provide thought leadership on regulatory topics and be proactive in identifying new opportunities or challenges within the regulatory environment.

Key Qualifications:

• Experience

  15+ years of experience in regulatory affairs, with a proven track record of success in the biotechnology or pharmaceutical industry, including significant experience in leadership roles.

  
  

• Expertise in Regulatory Submissions

  Strong experience in leading high-level regulatory submissions, particularly with IND/CTA, BLA, and MAA filings. Experience navigating complex, fast-paced regulatory environments is highly preferred.

  
  

• Therapeutic Area Knowledge

  Expertise in autoimmune diseases, hematology, or other immunologic-related therapeutic areas is highly advantageous. Knowledge of the challenges and regulatory requirements specific to these areas is a plus.

  
  

• Strategic Leadership

  Experience leading and developing high-performing teams. Demonstrated ability to work across functions and with senior leadership teams to execute on business objectives.

  
  

• Global Regulatory Knowledge

  Strong understanding of global regulatory frameworks, particularly in the U.S., EU, and other key international markets. Experience with both established and emerging regulatory agencies is preferred.

  
  

• Education

  A Master’s or Doctorate degree in life sciences or a related field. Regulatory affairs certifications (e.g., RAC) are highly desirable but not required.