Regulatory Studio Associate Director Precision Medicine Digital Health
1 week ago
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.
- 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.
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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