Assoc. Director, Regulatory Affairs (CMC) - Medical Device & Combination Products Job - United States
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. 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 an individual 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.
Reporting to the Director, the Associate Director in Medical Devices and Combination Product CMC is responsible for developing and implementing CMC regulatory strategies for Merck's pipeline products in accordance with global regulations and guidance’s, and is responsible for the preparation and submission of CMC dossiers for all assigned development products. Primary responsibilities include, but are not limited to:
- Serve as a Medical Device and Combination Product CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of global regulatory Medical Device and Combination Product CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Lead the development, communication, lifecycle management and review of the Medical Device and Combination Product CMC Regulatory Strategy Document for assigned projects.
- Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.
- Manage execution of Medical Device and Combination Product CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
- Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of Merck pharmaceutical products worldwide.
- Conduct all activities with an unwavering focus on compliance
- Experience in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- 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.
- B.S. in a biological science, engineering, or a related field (advanced degree preferred).
- Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or medical device field.
- The ideal candidate will have experience in Medical Device and Combination Product CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related medical device /pharmaceutical /biologic operations (e.g., manufacturing, process development, analytical, quality assurance).
- The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events. He/she must have superb collaboration skills, rapid, disciplined decision-making and critical thinking capabilities, and work well under pressure to be successful in this role.
- The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- The candidate must be proficient in English; additional language skills are a plus.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Job: Regulatory Affairs - CMC
Job Title:Assoc. Dir, Regulatory Affairs-CMC
Primary Location: NA-US-NJ-Kenilworth
Other Locations: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Medical, Microbiology, Biochemistry, Manager, Regulatory Affairs, Healthcare, Science, Management, Legal