Regulatory Affairs Senior Associate
WFA Digital Insight
As the remote job market continues to evolve, demand for skilled regulatory affairs professionals has grown significantly, with a notable 25% increase in job postings over the past year. The Regulatory Affairs Senior Associate role at Amgen stands out for its focus on digital skills and remote work, making it an attractive opportunity for those looking to advance their careers in this field. With the biotech industry expected to continue its rapid growth, candidates with a strong understanding of regulatory compliance and a passion for innovative medicine will be in high demand. Before applying, candidates should be prepared to showcase their expertise in regulatory document management and their ability to work collaboratively in a fast-paced environment.
Job Description
About the Role
The Regulatory Affairs Senior Associate role at Amgen is a vital position that plays a key part in the company's mission to serve patients living with serious illnesses. As a member of the regulatory affairs team, you will be responsible for assisting in the creation and submission of regulatory documents, including Investigational New Drug (IND) applications, Biologic License Applications (BLAs), and New Drug Applications (NDAs). You will work closely with the US Regulatory Lead to support US regulatory activities and ensure compliance with FDA regulations.The role requires a strong understanding of regulatory affairs and the ability to work collaboratively with cross-functional teams. You will be part of a dynamic team that is passionate about making a difference in the lives of patients, and you will have the opportunity to contribute to the development of innovative medicines that can change the course of patients' lives.
What You Will Do
- Assist the US Regulatory Lead in supporting US regulatory activities, including the development and submission of IND, BLA, and NDA applications
- Provide and maintain IND/BLA/NDA documentation support, including annual reports and amendments
- Create and maintain product regulatory history documents in the regulatory document management system
- Review the US 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
- Assist the Global or US Regulatory Lead in preparing supportive documentation for regulatory deliverables
- Coordinate the collection of functional documents in support of regulatory applications
- Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management
- Assist the USRL in managing the process for responding to FDA questions
- Provide primary authorship to routine regulatory correspondence, including annual reports
- Prepare regulatory packages and cross-reference letters to support investigator-initiated studies
- Complete regulatory forms to support agency communications, including FDA form 1571
What We Are Looking For
- Master's degree, or Bachelor's degree with 2 years of regulatory or pharmaceutical experience, or Associate's degree with 6 years of regulatory or pharmaceutical experience, or High school diploma/GED with 8 years of regulatory or pharmaceutical experience
- Strong understanding of regulatory affairs and FDA regulations
- Experience with regulatory document management and submission
- Excellent communication and collaboration skills
- Ability to work in a fast-paced environment and meet deadlines
- Strong analytical and problem-solving skills
- Experience with regulatory research and analysis
- Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)
Nice to Have
- Experience with electronic document management systems
- Knowledge of regulatory requirements for global markets
- Experience with project management and leadership
- Certification in regulatory affairs, such as RAC
- Experience with quality control and quality assurance
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work on innovative medicines that can change the course of patients' lives
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Remote work options and flexible working hours
- Access to cutting-edge technology and tools
- Comprehensive health insurance and wellness programs
How to Stand Out
- Make sure to highlight your experience with regulatory document management and submission in your application
- Showcase your knowledge of FDA regulations and Good Clinical Practice (GCP)
- Emphasize your ability to work collaboratively in a fast-paced environment and meet deadlines
- Be prepared to discuss your experience with regulatory research and analysis
- Consider obtaining certification in regulatory affairs, such as RAC, to stand out as a candidate
- Research Amgen's mission and values to demonstrate your passion for the company's mission
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