Bridging the difference® from reactive to proactive

“You rolled up your sleeves to provide us with a solution tailored to our specific business environment.—Senior Regulatory Affairs Manager, Global Biotechnology Firm

It’s easy to imagine:  a high-stakes regulatory directive suddenly affects you! The compliance team hands you a list of actual and potential impacts. Attorneys are busy sending you memoranda with limited practical guidance. Your employees have little appetite for change.  You fear if you don’t manage this challenge correctly, the company’s reputation and bottom-line will suffer and so will your career.

When people have to react suddenly to change and are forced to adhere to “hasty, heavy-handed, top-down compliance,” the results are often short-lived and regularly lead to additional non-compliance and enhanced punitive measures. Responding to regulatory directives is both science and art, requiring technical expertise and interpersonal skills. To achieve compliant and sustainable change, you must (1) be prepared to operate in a politically charged environment with transparency, (2) understand the regulatory nuances affecting your business, and (3) apply change management techniques to obtain senior sponsorship and enthusiastic employee buy-in.

  1. Understand the critical prerequisite of T.R.U.S.T.
  2. Recognize triggers that can derail negotiations with regulators.
  3. Develop strategies for getting “straighter” answers from Legal and accountability from Project Management partners.
  4. Recognize the importance of understanding “why” change is necessary and the multiple benefits of making the change.
  5. Identify resistance to change.
  6. Gain senior management sponsorship for your change.
  7. Transform angry, scared or resistant employees into active advocates for change.
  8. Communicate in a “clear, concise, and conspicuous” manner that fosters trust, accountability, and transparency.
  9. Reduce the possibility of acting on false assumptions.
  10. Apply new understanding of false assumptions to a real-work negotiations meeting.
  11. Strategize and prioritize to maximize your limited or “imaginary” compliance budget.
  12. Understand basic whistleblower compliance.

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