Companion Diagnostic Regulatory Affairs Manager

Are you a highly skilled and experienced regulatory affairs professional looking for a new challenge? Do you have a passion for advancing precision medicine and helping patients access life-saving treatments? Amgen, a leading biotechnology company, is seeking a dedicated Companion Diagnostic Regulatory Affairs Manager to join our team. In this role, you will play a vital role in ensuring the timely and successful development and approval of companion diagnostics for our innovative therapies. We are looking for someone with a strong background in regulatory affairs, a keen attention to detail, and a collaborative mindset to join our dynamic and diverse team. If you are ready to make a meaningful impact on patients' lives and advance your career with a global leader in biotechnology, we encourage you to apply for this exciting opportunity.

1. Lead and manage the regulatory affairs activities for companion diagnostics within Amgen's precision medicine portfolio.
2. Develop and implement regulatory strategies in collaboration with cross-functional teams to ensure timely and successful development and approval of companion diagnostics.
3. Serve as the primary point of contact with regulatory authorities for all companion diagnostic submissions and communications.
4. Monitor and interpret relevant regulations and guidelines to ensure compliance and provide guidance to internal stakeholders.
5. Prepare and submit high-quality regulatory submissions, including investigational device exemption (IDE), premarket approval (PMA), and premarket notification (510(k)) applications.
6. Collaborate with internal and external partners, including diagnostic companies, to ensure alignment and consistency in regulatory strategies and submissions.
7. Manage timelines and resources to ensure timely completion of regulatory deliverables.
8. Conduct risk assessments and provide regulatory guidance for companion diagnostic development and commercialization.
9. Coordinate and support regulatory inspections and audits related to companion diagnostics.
10. Proactively identify and mitigate potential regulatory risks and issues that may impact the development and approval of companion diagnostics.
11. Provide regulatory support and guidance to cross-functional teams, including clinical, medical, and commercial teams, to ensure compliance with regulatory requirements.
12. Contribute to the development and improvement of regulatory processes and standards to support the growth of Amgen's precision medicine portfolio.
13. Act as a subject matter expert for companion diagnostic regulatory requirements and serve as a resource for internal and external stakeholders.
14. Stay current with industry trends and changes in regulatory requirements related to companion diagnostics.
15. Represent Amgen at external meetings and conferences related to companion diagnostics regulatory affairs.
16. Mentor and train junior regulatory affairs team members to support their professional development.
17. Maintain accurate and up-to-date records and documentation in compliance with internal and external standards.
18. Adhere to Amgen's code of conduct, ethics, and compliance policies at all times.
19. Contribute to a positive and collaborative team environment and promote a culture of continuous improvement

According to JobzMall, the average salary range for a Companion Diagnostic Regulatory Affairs Manager in Thousand Oaks, CA, USA is $120,000-$150,000 per year. This range can vary depending on the specific company, experience level, and other factors.

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.