Senior Regulatory Scientist, Immunology - Remote

Merck; Austin (TX); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Retirement benefits including 401(k)

Paid holidays, vacation, sick days

Job summary

Merck & Co., Inc. is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to design and execute worldwide regulatory strategies for General Medicine with an emphasis on Immunology development programs.

You will act as the global single point of contact for regulatory strategy and work with World Health Authorities to optimize labeling and time-to-approval across multiple indications and external partnerships.

Qualifications

• B.S. or M.S. with a minimum of 10 years of relevant drug development experience with majority in regulatory.
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory.
• Strong strategic thinking, problem-solving and continuous learning mindset.
• Experience leading interactions with major Health Authorities (FDA, EMA).
• Global regulatory affairs experience in major markets (U.S., EU, Japan, China).
• Demonstrated leadership; ability to build and lead high-performing teams or projects.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval.
• Interacts with regulatory agencies and provides expert regulatory advice as the Global Regulatory Lead.
• Leads cross-functional teams to coordinate regulatory support for development programs and marketed products.
• Prepares and submits regulatory documents and manages communications with agencies.
• Leads regulatory meetings and due diligence activities as needed.

Skills

Drug Development

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Regulatory Communications

Regulatory Documents

Regulatory Processes

Strategic Leadership

Product Registrations

Regulatory Affairs Management

Regulatory Strategy Development

Regulatory Affairs Leadership

Education

Bachelor’s or Master’s degree in a relevant field

MD or PhD/ PharmD with regulatory experience

Job description

Merck & Co., Inc. is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to design and execute worldwide regulatory strategies for General Medicine with an emphasis on Immunology development programs.

You will act as the global single point of contact for regulatory strategy and work with World Health Authorities to optimize labeling and time-to-approval across multiple indications and external partnerships.