25 days old

Regulatory Affairs Manager - CMC

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114879420
Amgen

Job ID: R-86379
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Regulatory Affairs Manager, Chemistry, Manufacturing & Controls (RAMCMC). The RAMCMC will work out of our Cambridge MA site or our main corporate campus in Thousand Oaks, CA, or remotely.

The RAMCMC will assume a global regulatory CMC lead role for early oncology development clinical programs. Responsibilities will include the development of regulatory strategy for filing across multiple jurisdictions and communication of requirements and strategy to product teams and functional areas.

Additional responsibilities of the Regulatory Manager include:
  • Regulatory strategies securing regulatory approvals, and maintenance of product licenses
  • Leading Regulatory Affairs Chemistry Manufacturing and Controls (RA CMC) activities and deliverables
  • Provide mentoring and insight to the successful execution and implementation of CMC regulatory strategies
  • Collaboration with Amgen partners to develop and execute CMC regulatory activities
  • Determining minimum filing requirements
  • Contributes to one or more product teams; acts as product lead
  • Provide expertise in the development, communication, and implementation of global CMC regulatory strategies in support of department goals and product portfolio execution
  • Ensure regulatory documents (including quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents) are developed with high quality and delivered in a timely manner
  • Executes regulatory strategy with respect to preparation of submissions; follows critical RA CMC processes
  • Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities
  • Prepare for and participate in CMC-related agency interactions
  • Identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance
  • Raise CMC issues, progress, and metrics to management and contributes to process improvements
  • Incorporates changes in external regulatory guidance into CMC strategy and mentorship for product teams
  • Represent RA CMC on committees


Basic Qualifications

Doctorate degree

Or

Master's degree and 3 years of Regulatory CMC & Compliance and/or Quality experience

Or

Bachelor's degree and 5 years of Regulatory CMC & Compliance and/or Quality experience

Or

Associates degree and 10 years of Regulatory CMC & Compliance and/or Quality experience

Or

High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality experience

Preferred Qualifications
  • 3+ years' experience in regulatory, project management and product development in the Pharmaceutical/Biotechnology industry, preferably CMC
  • Degree in life sciences, biochemistry or chemistry


Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI114879420

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86379<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Regulatory Affairs Manager, Chemistry, Manufacturing & Controls (RAMCMC). The RAMCMC will work out of our Cambridge MA site or our main corporate campus in Thousand Oaks, CA, or remotely.<br><br>The RAMCMC will assume a global regulatory CMC lead role for early oncology development clinical programs. Responsibilities will include the development of regulatory strategy for filing across multiple jurisdictions and communication of requirements and strategy to product teams and functional areas.<br><br>Additional responsibilities of the Regulatory Manager include:<br><ul><li>Regulatory strategies securing regulatory approvals, and maintenance of product licenses</li><li>Leading Regulatory Affairs Chemistry Manufacturing and Controls (RA CMC) activities and deliverables</li><li>Provide mentoring and insight to the successful execution and implementation of CMC regulatory strategies</li><li>Collaboration with Amgen partners to develop and execute CMC regulatory activities</li><li>Determining minimum filing requirements</li><li>Contributes to one or more product teams; acts as product lead</li><li>Provide expertise in the development, communication, and implementation of global CMC regulatory strategies in support of department goals and product portfolio execution</li><li>Ensure regulatory documents (including quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents) are developed with high quality and delivered in a timely manner</li><li>Executes regulatory strategy with respect to preparation of submissions; follows critical RA CMC processes</li><li>Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities</li><li>Prepare for and participate in CMC-related agency interactions</li><li>Identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance</li><li>Raise CMC issues, progress, and metrics to management and contributes to process improvements</li><li>Incorporates changes in external regulatory guidance into CMC strategy and mentorship for product teams</li><li>Represent RA CMC on committees</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree<br><br>Or<br><br>Master's degree and 3 years of Regulatory CMC & Compliance and/or Quality experience<br><br>Or<br><br>Bachelor's degree and 5 years of Regulatory CMC & Compliance and/or Quality experience<br><br>Or<br><br>Associates degree and 10 years of Regulatory CMC & Compliance and/or Quality experience<br><br>Or<br><br>High school diploma / GED and 12 years of Regulatory CMC & Compliance and/or Quality experience<br><br><b>Preferred Qualifications</b><br><ul><li>3+ years' experience in regulatory, project management and product development in the Pharmaceutical/Biotechnology industry, preferably CMC</li><li>Degree in life sciences, biochemistry or chemistry</li></ul><br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.<br><br>A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/qq5QYqcrl6JjtAekUxpPD"> <p>PI114879420</p>

Categories

Posted: 2019-10-25 Expires: 2019-11-25

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Affairs Manager - CMC

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast