Associate Regulatory Affairs

**ABOUT AMGEN**

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

**ABOUT THE ROLE**

In this essential role, you will oversee the coordination and execution of FDA 2253 reporting submissions, while also serving as Amgen’s Digital Asset Management (DAM) librarian. In addition, this role will provide comprehensive administrative support to Operations staff throughout project lifecycles such as label changes. As a cross-functional position, you will collaborate closely with Regulatory Operations, engage with marketing teams as well as creative agencies to drive key commercial objectives. A strong proficiency in graphic design and video editing software—such as Adobe Creative Suite, Premiere Pro, and After Effects—is critical for success in this role. Additionally, proficiency with Veeva Promomats is highly preferred.

**Roles and Responsibilities**:

- Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
- Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
- Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
- Leverage company subscriptions to provide art procurement services in support of Amgen’s marketing initiatives.
- Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen’s various data repositories.
- Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
- Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
- Lead and facilitate Webex/MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
- Create infographics and presentation materials; perform technical editing and proofreading of process documentation.

**Required Knowledge and Skills**:

- Veeva PromoMats and RIM experience.
- Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
- Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through the appropriate lifecycle stages.
- Experience performing quality control (QC) checks on submitted materials to ensure compliance with US regulatory, legal, and brand standards.
- Ability to update and maintain metadata accurately within Veeva PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements.
- Proficiency in Veeva digital asset management (DAM) systems and experience handling various file types, metadata, licensing agreements, and usage rights.
- Familiarity with digital asset management (DAM) best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX.
- Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry.
- Experience troubleshooting and resolving metadata or workflow issues, including collaboration with cross-functional teams (e.g., Regulatory, Marketing, or Creative Agencies).
- Detail-oriented mindset with the ability to identify discrepancies and ensure data integrity across documents and metadata fields.
- Comfortable working in a fast-paced, highly regulated environment, managing multiple tasks and priorities within tight deadlines.
- Strong communication skills to effectively liaise with stakeholders and provide guidance on Amgen’s Veeva PromoMats processes and best practices.
- Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions with a strong knowledge of US FDA eCTD publishing tools
- Has knowledge of the US FDA guidance for submissions of promotional materials.
- Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools.
- Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel (with pivot tables), and Word.
- Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
- Develop and maintain clear, structured process documents, SOPs, and workflow guides.
- Design and run periodic and ad hoc reports using Veeva’s reporting functionality to support leaders