Regulatory Affairs Manager CMC

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus programs

Stock incentives

Flexible work arrangements

Job summary

A leading biotechnology company is seeking a Regulatory Affairs Senior Manager to contribute to product teams and provide strategic regulatory input. This leadership role involves executing regulatory strategies, engaging with regulatory agencies, and guiding teams in compliance with CMC requirements. The ideal candidate will have a robust educational background and experience in more than one aspect of regulatory affairs.

Qualifications

• Doctorate OR Masters + 3 years experience OR Bachelors + 5 years OR Associates + 10 years OR High school diploma/GED + 12 years experience.
• Experience in manufacture, testing, or distribution; Regulatory CMC experience preferred.

Responsibilities

• Generate and execute global and country-specific regulatory strategies.
• Provide CMC regulatory strategy for projects.
• Liaise with development, operations, and commercial teams.

Skills

Regulatory strategy

Risk assessment

Change management

Education

Doctorate

Masters

Bachelors

Associates

High school diploma/GED

Job description

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If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together by researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Regulatory Affairs Senior Manager Regional Regulatory Lead

Job Description

How might you defy imagination?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together by researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Live

What you will do

Let's do this. Let's change the world. The Regulatory Affairs Manager CMC contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and risk assessments; executes regulatory strategy for submissions; complies with RA CMC processes; identifies needs for process and strategy changes; reports issues to management.

Key Responsibilities Include:

• Generate and execute global and country-specific regulatory strategies
• Provide CMC regulatory strategy for projects, defining minimal filing requirements, submission strategy, and risk assessments
• Develop global dossiers for CMC content for submissions and amendments
• Support change management activities
• Develop response strategies and respond to health authority questions
• Liaise with development, operations, and commercial teams for alignment
• Liaise with local regulatory teams for filing strategy alignment
• Monitor and update data in tracking systems
• Follow regulatory processes for cross-product alignment

Win

What we expect of you

We seek a leader with these qualifications:

Basic Qualifications

Doctorate OR Masters + 3 years related experience OR Bachelors + 5 years OR Associates + 10 years OR High school diploma/GED + 12 years related experience

Preferred Qualifications

Experience in manufacture, testing, or distribution; Regulatory CMC experience

Thrive

What you can expect of us

We support your professional and personal growth, offering comprehensive benefits, bonus programs, stock incentives, time-off, flexible work arrangements, and more.

Join us for a career that defies imagination. Objects in your future are closer than they appear. Apply at careers.amgen.com.

Application deadline: Ongoing until position is filled.

Amgen is an Equal Opportunity employer and provides accommodations for individuals with disabilities.