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Senior Manager Regulatory Affairs CMC

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Mar 21, 2019

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

Amgen is seeking a Senior Manager Regulatory Affairs CMC to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

This role is responsible for
  • Strategic RA-CMC activities to influence and support the business objectives related to Amgen's initiatives
  • Engaging Health Authority regulators in support of Amgen
  • Tactical actions using external regulatory and industry knowledge to support projects/teams
  • Working internally to develop engagement strategy and alignment relative to new technologies/innovation/regulation/guidance and policy
  • Champion proactive influencing of the external regulatory environment in line with Amgen initiatives and objectives
  • Foster key long-term regulatory and industry relationships globally
  • Promote Amgen short and long-term CMC initiatives in alignment with Operations objectives across products in various phases of development
  • Further develop internal expertise and talent regarding CMC topics of current interest
  • Encourage staff awareness and create a culture of active participation and learning by sharing information externally and internally within RA-CMC
  • Partner effectively on RA CMC-specific issues with internal and external stakeholders (PD, Quality, GRAAS, R&D Policy)
  • Act as a conduit between Global and Regional RA-CMC
  • CMC-specific regulatory knowledge and experience
  • Ability to understand and communicate scientific information
  • Knowledge of, and experience with, Module 3 preparation throughout phases of development
  • Knowledge of Operations and Quality functions
  • Ability to communicate effectively at a variety of levels, convey regulatory strategy, listen, persuade, garner support and effectively drive change


Competencies
  • CMC- specific regulatory knowledge & experience
  • Experience engaging Health Authority regulators
  • Planning and organizing abilities, including familiarity with project management processes
  • Experience communicating and presenting clearly on strategic and business issues
  • Experience leading teams and critical projects in a global complex matrix environment
  • Excellent interpersonal and organizational skills
  • Professional collaboration and leadership skills
  • Experience managing cross-functional product and business initiatives
  • Experience implementing business change
  • Action oriented
  • Relationship building
  • Flexibility with day-to-day requirements
  • Conflict management
  • Strong oral and written communication skills
  • Professional negotiation, collaboration and leadership skills
  • Excellent interpersonal and organizational skills
  • Ability to provide direction and support for team members


Doctorate degree and 2 years of Regulatory experience

OR

Master's degree and 6 years of Regulatory experience

OR

Bachelor's degree and 8 years of Regulatory experience

OR

Associate degree and 10 years of Regulatory experience
  • Regulatory CMC experience
  • Health Authority engagement experience
  • Experience in manufacture, testing (QC/QA or clinical), or distribution
  • Pharmaceutical/Biotech industry
  • Trade Association and Industry Forum experience


Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages 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.

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.

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Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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