Senior Associate Regulatory Affairs

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Job summary

An established industry player is seeking a Senior Associate in Regulatory Affairs to support regulatory activities and documentation. In this pivotal role, you will collaborate with teams to ensure compliance with regulatory submissions and maintain essential documentation. This position offers the chance to work in a dynamic environment focused on improving patient outcomes while promoting your professional growth. Join a dedicated team that values innovation and collaboration, and contribute to meaningful projects that make a real difference in the lives of patients. Your expertise will help shape the future of healthcare.

Qualifications

• Masters degree or relevant experience in Regulatory Affairs.
• Strong communication and organizational skills are essential.

Responsibilities

• Assist in the creation and submission of regulatory documents.
• Support U.S. Regulatory Lead in compliance and documentation.

Skills

Strong communication skills

Organizational skills

Timeline management

Education

Masters degree

Bachelors degree

Associates degree

High school diploma / GED

Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Regulatory Affairs

What you will do

Lets do this. Lets 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 CROs / 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 communications
• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area 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 teams
• 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 dynamic professional we seek is a partner with these qualifications.

Basic Qualifications:

• Masters degree
• Or Bachelors degree & 2 years of Regulatory experience
• Or Associates degree & 6 years of Regulatory experience
• Or High school diploma / GED & 8 years of Regulatory experience

Preferred Qualifications:

• Masters degree in a biology, life science, health science curriculum, or regulatory science with 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 us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline: Amgen 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.

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 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 accommodation.