Regulatory Affairs Manager - CMC (Open to Remote)
regulatory manager cmc remote cmc regulatory patients team compliance r&r u&r imagination manager
September 2, 2022
New York, New York State
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Regulatory Affairs Manager - CMC
What you will do
Let’s do this. Let’s change the world. In this key role you will manage an external service provider and internal staff members within the Regulatory Optimization of Tactical and Strategic Support (Roots2) team. ROOTS2 is a team within the Global CMC Regulatory Affairs department responsible for execution of CMC submissions across countries, using standardized procedures to improve efficiency. This role will also manage, lead, and develop CMC regulatory staff in US and/or UK. This role requires a strong understanding of the CMC regulatory requirements across countries, phases of development and indications for biologic, synthetic, and/or biosimilar products as well as the ability to coordinate resources and tasks across Amgen global sites.
Key responsibilities of this CMC Regulatory Manager role include:
Oversight of an external service provider including, but not limited to, direct interactions with the vendor, oversight of resources and ways of working
Supervising assigned team members with respect to management, training, and resource planning
Support of CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for information across countries
Collaboration with leadership across CMC Regulatory functions and other functional leaders
Leading process improvements and documenting CMC Regulatory processes
Providing expertise and guidance to interdepartmental and cross-functional teams
Coaching and supporting junior staff’s career development
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Doctorate degree; OR Master’s degree and 3 years of Regulatory CMC or Compliance and/or Quality experience; OR Bachelor’s degree and 5 years of Regulatory CMC or Compliance and/or Quality experience; OR Associate’s degree and 10 years of Regulatory CMC or Compliance and/or Quality experience
CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products
Preparation of global CMC submissions across all phases of development
Degree in life sciences, biochemistry, or chemistry
Experience in leading Global regulatory CMC submissions and an understanding of global requirements and ICH guidance
Experience with manufacturing, process development, quality control, or quality assurance
Experience with training and/or managing staff
Project management experience
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and increase your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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