job title: Associate regulatory affairs(amgen)

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.

• MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates.

• 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 leadership in the analysis and interpretation of performance data.

Preferred Knowledge and Skills:

• Bachelor’s degree in graphic design, visual arts, marketing, or a related creative field.

• Minimum of +2 years of experience in marketing, pharmaceutical, or healthcare industries, with a strong understanding of regulatory requirements for promotional materials.

• Veeva Business Admin certification.

• Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer and distribution of marketing materials.

• Excellent attention to detail and ability to conduct thorough quality control checks on creative files for promotional content.

• Understanding FDA regulations and compliance requirements related to marketing materials and submissions.

• Strong analytical and problem-solving skills to ensure accuracy in digital asset retrieval, troubleshooting of file issues, validation, and distribution.

• Effective communication and stakeholder management skills to lead and participate in discussions regarding DAM timelines and creative file submission approvals.