VP Regulatory Affairs

143781
  • Competitive
  • San Francisco, United States
  • Permanent

Job Title: Head of Regulatory Affairs - Biologics and Dermatology

 

Company Overview: Join a leading biopharmaceutical company at the forefront of innovation in biologics and dermatology. Our client is committed to developing transformative therapies that address unmet medical needs and improve the lives of patients globally. Their is dedicated to pushing the boundaries of science to deliver safe and effective treatments across a range of dermatological conditions. They are working on products focused in both oncology and autoimmune diseases.

 

Position Overview: We are seeking a dynamic and experienced Head of Regulatory Affairs to lead our regulatory strategy and operations for biologics and dermatology. Reporting directly to the Chief Medical Officer, this role will be responsible for developing and implementing regulatory strategies to support the development, registration, and commercialization of biologic therapies in dermatology.

 

Key Responsibilities:

  • Develop and execute global regulatory strategies for biologic products in dermatology, ensuring alignment with corporate objectives and regulatory requirements.
  • Provide strategic guidance and leadership to cross-functional teams throughout the product development lifecycle, from preclinical development through to post-marketing activities.
  • Lead interactions with regulatory authorities, including the FDA, EMA, and other global agencies, to support product registrations, approvals, and lifecycle management activities.
  • Collaborate with internal stakeholders, including R&D, Clinical Development, Medical Affairs, and Commercial teams, to ensure regulatory compliance and successful product launches.
  • Stay abreast of evolving regulatory requirements and industry trends in biologics and dermatology, providing insights and recommendations to senior management.
  • Manage and mentor a team of regulatory professionals, fostering a culture of excellence, innovation, and continuous learning.

Qualifications:

  • Bachelor's degree in a scientific discipline; advanced degree (e.g., MS, PhD, PharmD) preferred.
  • Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry, with a focus on biologics and dermatology.
  • Proven track record of successfully leading regulatory submissions and approvals for biologic products in dermatological indications.
  • Strong understanding of global regulatory requirements and guidelines governing biologics and dermatology, including familiarity with FDA and EMA regulations.
  • Excellent leadership and communication skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
  • Strategic thinker with the ability to anticipate and mitigate regulatory risks while identifying opportunities for regulatory advantage.
  • Prior experience managing and developing high-performing regulatory teams is highly desirable.
Thomas Huynh Resourcer

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