Marketing Regulatory Affairs Specialist

Job Description:

• Quality Assurance Specialist for promotional materials, ensuring compliance with regulatory requirements.
• Evaluate creative file submissions and system metadata, ensuring completeness, accuracy, and adherence to licensing regulations.
• Collaborate with marketing teams to oversee the negotiation, renewal, and collection of usage rights for marketing materials.
• Leverage company subscriptions to provide art procurement services in support of marketing initiatives.
• Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing data repositories.
• Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management 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 meetings, including agenda preparation and accurate documentation of meeting minutes.
• Create infographics and presentation materials; perform technical editing and proofreading of process documentation.

Required Skills and Qualifications:

• 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 lifecycle stages.
• Experience performing quality control checks on submitted materials to ensure compliance with US regulatory 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 systems and experience handling various file types, metadata, licensing agreements, and usage rights.
• Familiarity with digital asset management best practices, including asset tagging, archiving, and retrieval.
• Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical industry.
• Experience troubleshooting and resolving metadata or workflow issues, collaborating with cross-functional teams.
• Detail-oriented mindset with 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 Veeva PromoMats processes and best practices.
• Experience creating Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions.
• Knowledge of US FDA guidance for submissions of promotional materials.
• Strong knowledge of Adobe Creative Suite and other design tools.
• Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel, and Word.
• Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
• Organizational skills, including email management and standard email templates.
• Develop and maintain clear, structured process documents, SOPs, and workflow guides.
• Design and run reports using Veeva s reporting functionality to support leadership in performance analysis.