Director, Regulatory Affairs – Companion Diagnostics Lead
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
The Principal Scientist/Director is responsible for the strategy and implementation of IVD/Companion Diagnostic (CDx) development plans working in partnership with internal development teams and IVD/CDx partners. The individual functions with a high degree of independence and works directly on programs. He/She is recognized as a regulatory expert in IVD/CDX development.
Under direction of the Sr. Director, IVD/CDx, the Principal Scientist/Director will be responsible for:
- Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
- Developing regulatory strategies for assigned products to enable timely registration of both therapeutic and diagnostic products by regulatory agencies.
- Providing regulatory leadership and input to internal teams involved with IVD/CDX development planning, including Diagnostic Development Teams, and to Joint Development Teams with diagnostic partners.
- Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory (e.g. PMA, 510(k), IDE) submissions.
- In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies.
- Review and approval of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers.
- Interacting with international regulatory colleagues and diagnostic partners to determine best practices & least burdensome regulatory paths towards development & global registration activities.
- Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively.
- Regulatory support of due diligence activities of external CDx/IVD companies that Merck may be considering as partners and other due diligence activities as needed.
- Required:Bachelor’s degree
- Preferred: M.S., PharmD., or PhD in biological science, chemistry, engineering or related discipline
Required Experience and Skills:
- A minimum of 5 years of relevant regulatory experience in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs.
- Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies is required.
- Outstanding interpersonal, communication and negotiation skills are required.
- Demonstrated leadership attributes; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Regulatory Affairs Liaison
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck