Career CategoryRegulatory
Job DescriptionSenior Associate - Regulatory AffairsWhat you will doLet's do this. Let's change the world. The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations.
Key Responsibilities:- Assist Regional Regulatory Lead to support regional regulatory activities
- Provide and maintain IND/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through RIM. Appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or Regional regulatory lead
- Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies
- Assist the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label.
- Coordinate collection of functional documents in support of regulatory applications
- Participate in GRT and assist the Global or regional regulatory lead in meeting management (eg, agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
- Assist the global or regional regulatory lead in managing the process for responding to regulatory agency questions.
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- 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 (E.G. FDA form 1571)
- 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
- Support the development and execution of GRT goals
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go-getter with these qualifications.
Basic Qualifications:Master's degree
OrBachelor's degree and 2 years of Regulatory Affairs experience
OrAssociate's degree and 6 years of Regulatory Affairs experience
OrHigh school diploma / GED and 8 years of Regulatory Affairs experience
Preferred Qualifications:- Bachelor's degree in Life Sciences and 2-3 years of Regulatory Affairs experience
- Experience setting up regulatory submissions
What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
