Sr. Associate, Nonclinical Regulatory Specialist

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr. Associate Nonclinical Regulatory Specialist

Lets do this. Lets change the this vital role you will partner with nonclinical scientists and functional representatives (eg Pharmacology Toxicology Pharmacokinetics & Drug Metabolism) global and regional regulatory leads and cross-functional stakeholders to enable regulatory readiness of nonclinical deliverables throughout the product lifecycle. This role offers a unique opportunity to contribute to the advancement of innovative therapies by serving as a trusted operational partner at the intersection of science regulatory affairs and submission management. As a member of the Research Data Management (RDM) organization you will provide operational and regulatory support by coordinating planning timelines communications and cross-functional execution to help ensure nonclinical regulatory deliverables are completed with quality consistency and alignment to regulatory expectations development objectives and Amgen quality standards.

Research Data Management (RDM) is a strategic execution function that partners with Research and Regulatory teams to enable the planning coordination and readiness of nonclinical regulatory deliverables across the product lifecycle. By combining nonclinical regulatory coordination document planning and operational execution RDM enables nonclinical teams to deliver high-quality regulatory deliverables that support global regulatory milestones. This role serves as a trusted operational partner to nonclinical teams and regulatory stakeholders helping translate nonclinical regulatory strategies into coordinated execution while providing visibility alignment and proactive support across functional stakeholders.

Responsibilities

Nonclinical Regulatory Specialist

• Partner with nonclinical scientists functional area representatives and regulatory stakeholders to coordinate activities supporting nonclinical regulatory planning document development and regulatory readiness.
• Develop maintain and communicate integrated timelines for nonclinical regulatory documents and deliverables ensuring alignment with development objectives and key regulatory milestones.
• Support execution of nonclinical regulatory strategies by coordinating cross-functional activities and facilitating delivery of nonclinical regulatory packages.
• Facilitate cross-functional planning meetings document decisions track action items and proactively follow up on commitments.
• Monitor progress identify risks or potential delays communicate issues to stakeholders and support development of mitigation plans.
• Serve as the day-to-day operational partner for assigned product teams fostering collaboration and alignment across scientific regulatory and operational functions.

Cross-Functional Collaboration & Operational Excellence

• Build strong collaborative relationships with nonclinical scientists regulatory partners and cross-functional stakeholders to facilitate effective communication and execution.
• Ensure activities are conducted in accordance with applicable regulatory requirements internal quality standards and established business processes.
• Support development and maintenance of standard operating procedures (SOPs) templates job aids and operational guidance documents.
• Identify opportunities to improve planning coordination communication and operational efficiency across nonclinical regulatory activities.
• Participate in continuous improvement initiatives that enhance regulatory readiness document planning and team effectiveness.
• Contribute to a collaborative team environment through knowledge sharing continuous learning and support of departmental initiatives.

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative science-minded professional with the following qualifications.

Basic Qualifications:

Masters degree
OR
Bachelors degree and 2 years ofdirectly relatedexperience
OR
Associates degree and 6 years ofdirectly relatedexperience
OR
High school diploma / GED and 8 years ofdirectly relatedexperience

Preferred Qualifications:

• Experience supporting pharmaceutical research and development or nonclinical drug development programs within the biotechnology pharmaceutical or life sciences industry.
• Understanding of nonclinical drug development regulatory requirements and the role of nonclinical data and documentation in global regulatory submissions.
• Experience coordinating complex cross-functional programs involving multiple scientific and operational stakeholders.
• Demonstrated project or program management skills including timeline development milestone tracking risk management and facilitation of cross-functional meetings.
• Demonstrated ability to build collaborative relationships and influence cross-functional teams without direct authority.
• Strong organizational skills with the ability to manage multiple priorities in a dynamic fast-paced environment.
• Excellent written verbal and interpersonal communication skills with the ability to build productive relationships across scientific and business functions.
• Experience coordinating scientific or regulatory documents throughout the document lifecycle.
• Demonstrated ability to identify opportunities to improve operational processes and implement practical solutions preferably using AI/ML applications
• Experience working with document management systems collaboration platforms and project management tools.
• Experience leveraging digital technologies collaboration platforms automation tools or AI-enabled solutions to improve operational effectiveness is desirable.
• Familiarity with Good Laboratory Practice (GLP) Good Documentation Practices (GDP) and global regulatory expectations for nonclinical documentation.
• Bachelors or advanced degree in a life science discipline regulatory affairs business or a related field.

As 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 well 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.

In 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.

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.

Sponsorship for this role is not guaranteed.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

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.

Salary Range