Senior Regulatory Specialist, Vaccines CMC 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.
Under direction from a Manager or Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for Merck's biological product franchise in accordance with domestic and international regulations and guidance’s, and is responsible for the preparation and submission of CMC sections for new biological products.
Primary responsibilities include, but are not limited to, Regulatory Responsibilities:
- Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Documents for smaller-scoped projects.
- Lead 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.
- Conduct all activities with an unwavering focus on compliance.
- B.S. in a biological science, engineering, or a related field Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
- Advanced degree
- At least three (3) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or licensure of biological or pharmaceutical products; or related fields.
- The candidate must be proficient in English; additional language skills are a plus.
- 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.
- Technical Skills:
- 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.
- Demonstrates an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the continued market supply of Merck Biological products worldwide.
- Leadership Skills:
- 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.
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 firstname.lastname@example.org.
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Job: Regulatory Affairs - CMC
Job Title:Sr. Spclst, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Biochemistry, Microbiology, Engineer, Pharmacy, Scientific, Science, Engineering, Healthcare