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 125-year legacy. 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 Director, Regulatory CMC, Devices and Combination Products responsibilities include, but are not limited to the following:
This position will lead development of regulatory strategy and execute the preparation, maintenance of chemistry, manufacturing and controls (CMC) sections of regulatory submissions and responses to agency questions for worldwide registration for the assigned medical device or device aspect of combination products.
Regulatory submissions are global and include Investigational New Drug applications, 510(k) clearances, Worldwide Marketing Applications and maintenance of marketed products (post approval submissions and renewals), as well as associated responses to agency questions for medical devices and the medical device aspect of combination products.
Assures that filed information maintained following applicable departmental procedures/tools and databases and maintains appropriate documentation to maintain CE marked products within regulatory compliance.
Serves as a medical device and combination product Subject Matter Expert to drug product CMC experts in product development and marketed product teams.
Develops and maintains expert knowledge of current global regulatory CMC requirements for medical devices and combination products for initial clearance, registration, re-registration and post-approval changes.
Provides scientific and regulatory guidance to Regulatory CMC experts during development and for marketed products and assures that the information available will meet regulatory expectations for intended countries.
Identifies and resolves technical and operational issues associated with regulatory strategy and submissions; collaborates with peers to resolve cross-functional obstacles.
Looks for innovative and scientifically sound approaches to gain approval and clearance of medical devices and associated products.
Participates in the development of business processes associated with the CMC aspects of medical devices and combination products.
Represents Merck at FDA project-specific meetings as well as industry meetings.
Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance, medical devices).
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, communication, and interpersonal skills.
Bachelor's Degree in pharmacy, chemistry, engineering or a related discipline with a minimum 15 years of CMC/regulatory affairs experience in small molecules, biologics, vaccines, medical devices and/or combination products OR a post-graduate degree with a minimum of 10 years of CMC/regulatory affairs experience in small molecules, biologics, vaccines, medical devices and/or combination products
Minimum 5 years regulatory CMC experience with medical devices and/or combination products.
Strong oral and written communication skills; effective problem solving and decision making skills; innovative, flexible and collaborative with demonstrated leadership skills.
Strong knowledge in regulatory guidances and expectations for Combination Products
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of... people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.