Senior Associate Regulatory Affairs
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Senior Associate Regulatory AffairsLive
What you will do
Lets do this. Lets change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
- To coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements.
- To manage and execute of the preparation, delivery and electronic archiving of documentation for inclusion in US regulatory submissions
- To assist the Global Regulatory Lead to manage GRT interactions
The responsibilities of the Regulatory Affairs Senior Associate position are:
- Assist US Regulatory Lead to support regional regulatory activities (e.g. IND submissions and agency meetings)
- Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through Amgen systems and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Collaborate with CROs / partners to support site initiation
- Coordinate collection of functional documents in support of regulatory filings
- Participate in GRT to support execution of regulatory strategy
- Coordinate QC of regulatory documentation (e.g. briefing materials)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Complete regulatory forms to support agency communications
- Provide regulatory support through cross-functional interactions in work package teams (eg. commercial and evidence generation teams)
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with GRT
- Actively support regulatory compliance
- Support the development and execution of GRT goals
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a leader with these qualifications.Basic Qualifications:
- Doctorate degree Or
- Masters degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum Or
- Bachelors degree and 2 years of Regulatory experience
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to resolve conflicts and develop a course of action
- Cultural awareness and sensitivity to achieve global results
- Planning and organizing abilities
- Able to prioritize and manage multiple activities
- Ability to deal with ambiguity
- Organizational savvy
- Negotiation skills
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we 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 maximize 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request an accommodation.
Join UsIf 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.