Senior Vice President and Head, Regulatory Affairs

This is a Retained Search.  Our client is dedicated to preventing blindness.  They are developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders.  Reporting to the CEO, the SVP & Head Regulatory Affairs will provide the leadership and strategic direction for the company’s product portfolio strategy including due diligence activities for in-licensing of assets. You will be responsible for creating the Regulatory strategy and providing leadership to the organization, prioritizing the pipeline, and overseeing compounds through development for regulatory approval, as well as life cycle management opportunities for already approved and marketed products. You will oversee the implementation of regulatory strategies at all stages of development to facilitate the earliest possible approvals of the company’s regulatory applications for new products and line extensions.   You will also serve as a member of the company’s Executive Team.  Now is an exciting time to join this rapidly growing organization!

Responsibilities:

  • Lead regulatory activities with an emphasis on formulating and overseeing the implementation of regulatory strategy and activities needed to secure approval of new drugs.
  • Provide strategic oversight and lead the optimization of the Global Regulatory function for all products.
  • Provide regulatory risk assessment for projects based on regulatory precedence and product characteristics.
  • Serve as primary liaison with FDA, EMA and other global regulatory authorities for high sensitivity/impact items.
  • Review and provide oversight of all submissions and manage associated interactions with regulatory bodies.
  • Provide direct oversight of all regulatory functions pertaining to the Pre-Approval and Post-Approval Submissions and the compliance and graphic functions of Labeling Compliance to assure the goals set forth for the Company’s internal and external R&D pipeline and marketed products are met.
  • Provide regulatory guidance to product development teams from development through lifecycle management for marketed products, managing all regulatory activities.
  • Provide regulatory input and strategic assessment of regulatory issues related to potential in license compounds and acquisition candidates during due diligence processes.
  • Collaborates with BU leadership and provides strategic regulatory input on NDAs, marketed products and life cycle management issues.
  • Oversees regulatory matters with license partners.
  • Promotes compliance and undertakes measures designed to sustain compliance with all applicable Federal health care programs, FDA requirements and company policies.
  • Serve as subject matter expert in global regulatory processes, laws, and regulations, particularly within the U.S. with FDA.
  • Responsible for overseeing the systems/processes to monitor the regulatory environment for changes, and to assess the impact on products and programs to ensure attainment of financial and strategic goals.
  • Manage and mentor a regulatory team of direct reports.

Qualifications:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
  • 15+ years of Drug Development and Regulatory Affairs experience. Ophthalmology and/or Retinal disease experience highly desired but not required.
  • Previous management and leadership experience leading direct teams and through a matrix environment.
  • Track record of successful NDA, BLA and/or MAA filings.
  • Must have experience working directly with the FDA and global regulatory authorities.
  • Expertise in communication and organizational skills as well as hands-on experience with international clinical development. Track record of successful interactions with regulatory and health authorities on an international level.
  • Demonstrated knowledge of worldwide drug guidelines and regulations and in particular US FDA.
  • Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity. Strong relationship management and interpersonal skills are essential.

Interpersonal, Leadership, and Soft Skills:

  • Proven ability to hire, build, and lead a Regulatory team.
  • Must be humble with low ego.
  • Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity. Strong relationship management and interpersonal skills are essential
  • Natural collaborator who enjoys working on a cross-functional team.
  • Proven ability to manage multiple projects, set priorities and meet deadlines.
  • Must be comfortable being an individual contributor, a team player, and a team leader.
  • Proven ability to lead cross functional teams, serving as a strategic and tactical bridge between multiple areas.
  • Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.

 

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