Vice President, Clinical & Regulatory Affairs

Job ID: | Position Type: Full Time, Exempt

location

Remote

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success.   We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

Duties:

  • Provide market segment leadership and subject matter expertise for the Clinical and Regulatory Affairs sphere. Develop and execute science-based clinical and regulatory affairs solutions for the regulated life sciences industry.
  • Must be able to speak to and demonstrate knowledge in the following areas: medical devices, drugs, biologics, nutraceuticals, homeopathic drugs, IVD, and combination products as it relates to clinical and regulatory affairs primarily in the US, EU and other international markets
  • Accountable for growing Pharmatech’s Clinical and Regulatory Affairs sphere through sales development, outstanding project management and exceptional client relationship management.
  • As a member of the senior leadership team, participate in strategic and operational decision-making processes necessary for the successful attainment of the organization’s initiatives.
  • Primary responsibility for managing all aspects of Profit & Loss performance including resource allocation, project proposal development, expense control and the development of annual budgets and monthly forecasts.
  • Assemble world-class consulting teams by actively supporting recruitment efforts, including negotiating compensation, and providing growth and mentorship opportunities.
  • Champion and execute Pharmatech’s culture to heighten employee engagement and maximize retention of top talent.  Prepare and communicate annual performance reviews.
  • Maintain an awareness and understanding of changes to Global International regulatory requirements as it relates to current drug therapy categories with the goal of assessing potential impact on current client operations.

Qualifications:

  • Bachelor or Master’s Degree with a scientific or engineering related major is required
  • Strong leadership skills with at least 10 years of demonstrated leadership and experience in the regulatory affairs area. Preferably with experience running a successful and profitable clinical and regulatory affairs consulting practice.
  • Expertise in following registrations: 510K (including De Novo) devices, Pre-Market Approval (PMA) devices, MAF’s, IVD, NDA, ANDA, IND and BLA for pharmaceutical and biotech products
  • Strong Regulatoryease technical writing capabilities specific to regulatory activities
  • Outstanding personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations.
  • Able to effectively communicate to various audiences, including C-level and BOD level client personnel.  Exceptionally strong written and oral communications is a must.
  • Capable to travel and work remotely at client sites throughout the United States and internationally

 

 


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