**Description** The Associate Director, DRA Product Labeling Operations role will lead and manage coordination of operational activities of labeling/packaging matters for assigned BI Pharmaceuticalsmarketed products including: label compliance reviews, development and maintenance of packaging components, liaison between the corporate design office, graphic offices, and production sites for implementation per established timelines and in line with local regulations, corporate compliance and business objectives.Manage overall operational activities to support late-stage development labeling for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product Groups.Participate as a PLRT member contributing to the compliance and grammatical aspects of the content of labeling. Additionally, when required present packaging concepts for consideration.Continuously evaluate innovative opportunities to improve efficiency and execution of process to support labeling initiatives in compliance with corporate and local regulatory requirements.Provide training, advice, and mentoring to affected cross-functional colleagues and within Labeling Operations, as appropriate, for labeling related procedures.Provide functional support to label management as needed and assist/manage overall operational activities of the DRA Labeling Operations Group to keep priorities in line with business goals.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. **Duties & Responsibilities** + Independently Manage Operational Labeling Activities: Ensure labeling components for late stage development projects, new product launches and post- marketing labeling revisions comply with Corporate Design guidelines and local regulations. Influence critical labeling operational activities as appropriate to successfully generate quality documents with internal customers and with FDA to achieve timely labeling reviews/approvals in alignment with business objectives. Work closely with staff and project/product responsible DRA colleagues to a) plan, review, approve required labeling components for filing of required information to FDA, including e.g., SPL, Artwork, Word files and b) identify/resolve issues associated with new product packaging and labeling development. When necessary, provide individual product support for these activities. + Independently communicate via established procedures with SLCI responsible or labeling services to revise and create artwork for various labeling components for assigned BIPI marketed products. Ensure that timelines for revised artwork are adhered to as to minimize impact on production. + Interact with Corporate Design Office as needed for US labeling changes to ensure consistency with design guidelines or requests for local deviations. + In collaboration with Supervisor and upon Supervisor request, provide training (using available training materials or create new training materials)to affected cross-functional colleagues, as appropriate, for labeling related procedures. Mentor the BIPI RA Product Labeling Operations staff responsible for operational management in collaboration with Supervisor. + Continuously identify needs and develop and/or maintain local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements. + Labeling Submissions to FDA - Prepare labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling Content, GSS and RA Product Groups. Prepare leaf title documents and ensure all labeling files are ECTD compliant.Responsible for the labeling section of NDA Annual Reports. + Maintain and improve Regulatory Professional Knowledge: demonstrate excellent labeling regulations knowledge.Seek to improve knowledge on a continual basis to support US labeling responsibilities, processes and management. Review regulatory developments to keep the company abreast of changes in the US regulatory environment impacting product labeling and packaging. + Assist in training of DRA colleagues and individuals from other departments in the area of package labeling generation and review. Maintain excellent knowledge of applicable corporate/company SOPs, guidelines and working instructions. In collaboration with Supervisor, represent DRA Product Labeling Operations on localworking groups. + Provide guidance, training and technical expertise to labeling specialists and labeling managers for the preparation and approval of Structured Product Labeling (SPL) files. + Regular and timely communication with stakeholders is essential to assure progress of new and revised labeling revisions throughout the review cycle, while considering local regulatory and corporate process/compliance requirements. + The critical business impact of labeling decisions may affect all pharmaceutical (global) operations for BIPI marketed products and may have substantial commercial impact, including marketplace availability to patients. + Certain labeling revisions made at the request of local authorities or those as a result of new data at the local level, may impact the Corporate Core Data Sheet which eventually impacts worldwide labeling. **Requirements** **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.