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.
Reporting to the Director, the Associate Director is responsible for implementing CMC regulatory strategies for Merck's vaccine products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Primary responsibilities include, but are not limited to:
Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
Manage execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
Prioritize execution of submissions and lead opportunities to maximize submission efficiency.
Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of Merck vaccine products worldwide.
Identify appropriate opportunities for, lead preparation for and execution of consultation with Health Authorities.
Conduct all activities with an unwavering focus on compliance.
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Demonstrated ability to generate innovative solutions to complex regulatory 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, interpersonal and negotiating skills.
B.S. in a biological science, engineering, or a related field. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.
At least five (5) years of relevant experience with an advanced degree, including biological/pharmaceutical research; manufacturing, testing, or licensure of vaccine or biological products.
Must be proficient in English
Advanced degree in a biological science, engineering, or a related field. Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.
At least ten (10) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or licensure of vaccine or biological products.
3 openings. Employer will assist with relocation costs.
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.