Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Position Description:

• Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Project Lead and provide CMC leadership within Regulatory and on cross-functional teams for the assigned biological projects.  Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.
• Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory Chemistry, Manufacturing and Control requirements and identification of potential risks.
• Manage execution of CMC documentation including Investigational New Drug Applications, Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization Applications, or Post approval / variations, 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 Chemistry, Manufacturing and Control management, as needed
• Conduct all activities with an unwavering focus on compliance

Position Qualifications:

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

• 5 years of Regulatory CMC related experience, relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field.

• Experience in biologics Regulatory CMC preferred.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.