Career Category

Job Description

Title: Global Regulatory Operations Sr Associate - Submission Management

Reports to: Sr. Manager, GRAAS Operations

Location: North America - Remote Worker

Job Summary

Working at Amgen
At Amgen you’ll experience a work environment where employees strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health. Amgen provides the working environment you have always strived for - A perfect combination of science and entrepreneurship that brings therapies to market by people that have a true passion for their work.

Our culture is what makes Amgen a special place to work. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Take a few minutes to hear what some of our current staff members are sharing about working at Amgen. Click HERE

Responsibilities: 

- To lead the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers -

- ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities.

- Bring strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions.

Key Activities

•Creation and submission of regulatory dossiers according to agency requirements, eCTD Guidance & Specifications and agreed upon timelines

•Preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards

•Contribution to submission strategy and timing

•Contribution to the filing of ex-US regional submissions

•Development of global training and documentation for publishing

•Creation and maintenance of technical manuals, training documentation and SOPs

•Participation in information system and software update projects as well as ongoing system validations

•Interaction with vendor and supplier staff

•Supervision of contractors in the conduct of their duties

Knowledge and Skills

•Experience working in and leading teams

•Understanding of the industry and business principles for a regulatory operations department

•Advanced knowledge of the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications

•Advanced knowledge of the submission and maintenance of global Clinical Trial and Marketing Applications

•Advanced knowledge of eCTD, eCTD Specifications and eCTD software

•Advanced knowledge of MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing

Basic Qualifications

Bachelors Degree

2+ years of regulatory affairs experience

Preferred Qualifications

•Experience in an regulatory operations-focused role

•Advanced experience publishing eCTD submissions

•Advanced experience with standard software utilized by regulatory publishing groups

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.

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact TalentAcquisitionInquiries@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview.