Associate Regulatory Affairs

Career Category Regulatory 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 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 AIN working hours for this position This position supports the Regulatory Promotion and Material Compliance activities serving Amgen s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications EQUAL OPPORTUNITY STATEMENT 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 with 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 an accommodation