Career CategoryRegulatory
Job DescriptionSenior Associate - Regulatory Affairs What you will doLet's do this. Let's change the world. In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
- Assist U.S. Regulatory Lead to support regional regulatory activities. Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with U.S. Regulatory Lead
- Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance with submissions to regulatory agencies
- Support U.S. Regulatory Lead in review of HA interaction activities
- Collaborate with CRO's / partners to support site initiation, as applicable
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy
- 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
- Approve drug shipment for Amgen and Investigator Initiated Studies
- Complete regulatory forms to support agency communicationsProvide regulatory support to Commercial, Medical and Clinical departments through crossfunctionalinteractions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metricsDescription
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- 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 self-starter with these qualifications.
Basic Qualifications:Master's degree
Or
Bachelor'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:- Master's degree in a biology, life science, health science curriculum, or regulatory sciencewith biology curriculum
- Regulated industry, science or clinical practice experience
- Timeline management
- Strong communication skills - oral and written
- Organizational skills
- Ad hoc meeting support
- Agendas, minutes
What you can expect of 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.comSalary Range83,974.90USD -113,613.10 USD
