Regulatory Studio Associate Director Precision Medicine Digital Health

1 week ago


Millburn, New Jersey, United States Ampcus Incorporated Full time
Job Title:

Regulatory Studio Associate Director Precision Medicine & Digital Health

Company:

Ampcus Incorporated

Location:

Remote

Job Summary:

We are seeking a highly experienced Regulatory Studio Associate Director to lead our global regulatory strategy for precision medicine and digital health. The successful candidate will have a strong background in regulatory affairs, with a focus on precision medicine and digital health.

Responsibilities:
  • Develop and implement global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health products.
  • Lead cross-functional teams to develop and submit regulatory filings, including clinical trial applications and marketing authorizations.
  • Collaborate with global regulatory authorities to ensure compliance with regulatory requirements and to resolve any issues that may arise.
  • Develop and maintain relationships with key stakeholders, including regulatory authorities, industry partners, and internal teams.
  • Stay up-to-date with the latest regulatory developments and trends in precision medicine and digital health.
Requirements:
  • Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related field.
  • At least 5 years of experience in regulatory affairs, with a focus on precision medicine and digital health.
  • Proven track record of leading global regulatory strategies and teams.
  • Strong knowledge of regulatory requirements and guidelines in precision medicine and digital health.
  • Excellent communication and interpersonal skills.
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your application.



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