Regulatory Affairs Director with Strategic Expertise

6 days ago


Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time
Company Overview:
Bicycle Therapeutics is a dynamic pharmaceutical company committed to delivering innovative treatments for challenging diseases. Our team is driven by a passion for innovation and a commitment to excellence.

Salary:$220,000 - $270,000 per year

Job Description:
We are seeking a seasoned Regulatory Affairs Director with Strategic Expertise to lead our safety and pharmacovigilance initiatives. This key role will oversee the strategic direction of our safety and pharmacovigilance function, ensuring compliance with global regulatory requirements. You will collaborate closely with senior executives to integrate safety and pharmacovigilance considerations into overall business strategies and clinical development plans.

Key Responsibilities:
  • Develop and implement comprehensive safety and pharmacovigilance strategies aligned with our mission and goals.
  • Collaborate with senior executives to integrate safety and pharmacovigilance considerations into overall business strategies and clinical development plans.
  • Manage and lead the patient safety and pharmacovigilance function, including oversight of activities, operations, and continued evolution toward a best-in-class organization.
  • Represent Bicycle in interactions with regulatory agencies, industry consortia, and external stakeholders on drug safety matters.


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