This position located in Pennsylvania, reports to the President and CEO. As the chief regulatory and quality officer of the company you will be responsible for providing vision, leadership and strategic guidance. You will have:

· Have total fiscal accountability for the Regulatory department including strategy and submissions (internal and external for clients)

· You will work with the President & CEO on acquisition and related due diligence in functional areas of responsibility.

· As a member of the RCRS Executive Team, be actively involved in all aspects of successfully managing and building a global emerging Clinical Services leader.

· Champion the priorities of the Quality & Compliance activities of the company.

· Develop excellent working relationships with all regulatory agencies resulting in rapid, worldwide approvals for internal and external (client) projects.

· Have direct international accountability for regulatory and quality strategy.

· Serve as RCRS focal point with all governmental regulatory organizations. Build a strong foundation for corporate credibility.

· Reviews and recommends changes for labeling, marketing, clinical protocols for regulatory compliance (internal and client driven projects).

· Contributes to clinical project teams, providing expertise and guidance on regulatory matters.

· Hires, develops and directs members of the Global Regulatory & QA teams. Direct line and matrix organization.

· Responsible for departmental strategies, budgets and identifies resources required.

· Evaluate the functional strengths and developmental areas of department and focus on improving the critical issues in areas of importance.

· Constantly assess and improve RCRS quality standards.

· Identify opportunities using creative and progressive QA practices to maximize business potential.

· Developing and establishing QA systems, strategies, policies / plans and programs - managing their implementation and ensuring that relevant standards are established and complied with.

Candidate Requirements:

1. Seasoned Regulatory, Quality & Compliance professional with a minimum of 10 years of Pharma / Bio-Pharma experience.

2. Proven track record of global regulatory submissions and strong existing relationship with key regulatory agencies.

3. Doctorate degree in Life Sciences, Pharmacy or Medicine (MD or PhD preferred); Regulatory Affairs Certification (RAC) preferred.

4. Experience with US and International agencies (Europe, Asia and Japan).

5. Results driven with ability to operate in a high demand environment - meets all deadlines.

6. Expected to be a pre-eminent example of the company's values as demonstrated through the following behaviors: entrepreneurship, teamwork, quality and integrity.

7. Strong team player capable of working collaboratively with colleagues in their department and in all functions; track record of proven leadership in successful and well respected RA/QA organizations.

8. Strong entrepreneurial abilities, sense of urgency skills coupled with excellent communication and presentation skills.

9. Experience in acquisitions, functional assessment and due diligence would be advantageous.

10. High degree of presence and authority without arrogance; represents RCRS with professionalism and credibility.

11. Willingness to travel up to 40% of time internationally.

Compensation:

A compensation package will be designed to attract outstanding talent and will include an attractive base salary, incentive compensation and benefits.