Executive Director, Regulatory Operations

This biopharmaceutical company is developing and commercializing an innovative pipeline of cancer therapies.  They are seeking an Executive Director, Regulatory Operations who can plan and build out the Regulatory Operations function and infrastructure for the organization.  Reporting into the SVP of Regulatory & Quality, you will formulate the vision and strategy to achieve a best-in-class, fit for purpose Regulatory Operations organization for this commercial stage biotechnology company.  Our client offers an innovative pipeline, a strong cash position, and a collaborative company culture.  With one approved product and another approval pending, now is an exciting time to join this growing organization!

Responsibilities:

  • Be a strategic thought partner to the SVP of Regulatory on current and future direction of Regulatory Operations initiatives and strategies.
  • Envision and implement a fit for purpose RIM across Regulatory, R & D, and the enterprise.
  • Proactively anticipate and mitigate regulatory operational risks and develop internal processes to ensure operational excellence and compliance with global regulatory requirements.
  • Establish a Regulatory Project Management team to partner with Regulatory Strategists and CMC Regulatory to ensure flawless execution of regulatory strategy to meet corporate objectives.
  • Develop and maintain a Regulatory Affairs Quality Management System including a system for providing training in partnership with Quality Assurance.
  • Establish electronic submission standards, policies, and operation procedures.
  • Build and maintain a communication strategy and platform for the Regulatory, Quality and Medical Writing organization.
  • Accountable to concisely articulate regulatory operational risks and develop risk-mitigation strategies as well as evaluate opportunities to accelerate development in a fast-paced, dynamic environment.
  • Accountable for actively maintaining a contemporary working knowledge of the global regulatory environment and identify and communicate the implications of identified regulatory trends that may impact the business.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Prepare, plan and implement new processes and policies to improve efficiency of the Company.

Qualifications:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, MBA or PhD) preferred.
  • 15+ years pharmaceutical industry experience with responsibility for major aspects of strategic planning, implementation, Regulatory Operations and Project Management.
  • Demonstrated deep understanding of Regulatory Information Management.
  • Project management expertise demonstrated ability to lead complex outsourcing projects.
  • Experience building and leading a fit for purpose Regulatory Operation organization with significant direct exposure to clinical development.
  • Proven record of leading and driving business process transformation and organizational culture change.
  • Demonstrated ability to lead and inspire a diverse set of internal/external partners and stakeholders.
  • Demonstrated ability to work across functions.
  • Outstanding communicator, able to effectively communicate ideas and data, verbally and in written form.
  • Forward thinker with the ability to recommend, influence and implement organizational change and continuous innovation.
  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
  • Ability to effectively lead and drive an ecosystem with diverse partners and suppliers.
  • Cross functional partnering skills, team-oriented and ability to drive outcomes are necessary skills in the environment.
  • Experience working within corporate alliance partnerships is highly desirable.
  • Must be solution oriented with demonstrated skills to innovate, analyze, solve problems, and foster a collaborative working environment.
  • Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.

This is a hybrid position and the Executive Director must be in the office 1-2 times per quarter. Our client has offices in the NY/NJ area and also in the Boston area.  Candidates in the Northeast are strongly preferred.

The budgeted salary range for this position is US$275,000 to $300,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

 

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