Boehringer Ingelheim
Associate Director/Manager, Product Labeling (Hybrid)
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Overview
Associate Director/Manager, Product Labeling (Hybrid) at Boehringer Ingelheim. Lead and manage the coordination of labeling/packaging for Boehringer Ingelheim Pharmaceutical Inc. marketed 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. This role will 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. The role will participate as a PLRT member contributing to the compliance and grammatical aspects of labeling content. When required, the incumbent will present packaging concepts for consideration. The position holder will continuously evaluate innovative opportunities to improve efficiency and execution of processes to support labeling initiatives in compliance with Corporate and local regulatory requirements. The incumbent will provide training, advice, and mentoring to affected cross-functional colleagues and within Labeling Operations, as appropriate, for labeling related procedures. The incumbent will provide functional support to label management as needed and assist/manage the overall operational activities of the DRA Labeling Operations Group to keep priorities in line with business goals. Duties & Responsibilities Independently communicates via established procedures with SLCI labeling services to revise and create artwork for various labeling components for assigned Boehringer Ingelheim marketed products. Ensures that timelines for revised artwork are adhered to in order to minimize impact on production. Interacts 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, provides training (using available training materials or creating new training materials) to affected cross-functional colleagues for labeling related procedures. Mentors the Boehringer Ingelheim RA Product Labeling Operations staff responsible for operational management in collaboration with Supervisor. Continuously identifies needs and develops and/or maintains local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements. Provides guidance, training, and technical expertise to labeling specialists and labeling managers for the preparation and approval of Structured Product Labeling (SPL) files. Collaborates with planning function to escalate and present requests to senior management to deviate from compliance implementation dates.
Operational Labeling Activities
Ensures labeling components for US late-stage development projects, new product launches, and post-marketing labeling revisions comply with Corporate Design guidelines and local regulations. Influences 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. Works closely with staff and project/product responsible DRA colleagues to plan, review, approve required labeling components for filing with the FDA and to identify/resolve issues associated with new product packaging and labeling development. When necessary, provides individual product support for these activities.
Maintain and Improve Regulatory Knowledge
Demonstrates excellent labeling regulations knowledge and seeks to improve knowledge on a continual basis to support US labeling responsibilities, processes, and management. Reviews regulatory developments to keep the company abreast of changes in the US regulatory environment impacting product labeling and packaging. Assists in training of DRA colleagues and individuals from other departments around package labeling generation and review. Maintains excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions. In collaboration with Supervisor, represents DRA Product Labeling Operations on local working groups.
Labeling Submissions to FDA
Prepares labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling Content, GSS, and RA Product Groups. Prepares leaf title documents and ensures all labeling files are eCTD compliant. Responsible for the labeling section of NDA Annual Reports.
Requirements
Associate Director: Bachelors degree with a focus in Biology or related field with eight to ten (810) years experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required, OR Masters degree with a focus in Biology or related field with six (6) years experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required. Minimum five (5) years labeling operations experience. Manager: Minimum B.S./B.A. degree with 58 years pharmaceutical experience in DRA or scientific discipline, with 2 years labeling experience preferred to understand labeling decisions; thorough knowledge of current FDA regulations, guidance documents, and initiatives; demonstrated ability to manage teams and projects; excellent proofreading/editing; and strong communication skills.
Eligibility Requirements
Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older
Compensation
This position offers a base salary typically between $115,000 and $222,000. It may be eligible for a role-specific bonus or other compensation elements. For an overview of benefits, please click here. Why Boehringer Ingelheim?
With us, you can develop your own path in a company that values diversity and inclusion and is committed to making millions of lives better. We support employee development and offer a culture that is independent, authentic, and bold. We provide programs to support health and wellbeing and opportunities to contribute to global accessibility to healthcare. Want to learn more? Visit https://www.boehringer-ingelheim.com #J-18808-Ljbffr
Associate Director/Manager, Product Labeling (Hybrid) at Boehringer Ingelheim. Lead and manage the coordination of labeling/packaging for Boehringer Ingelheim Pharmaceutical Inc. marketed 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. This role will 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. The role will participate as a PLRT member contributing to the compliance and grammatical aspects of labeling content. When required, the incumbent will present packaging concepts for consideration. The position holder will continuously evaluate innovative opportunities to improve efficiency and execution of processes to support labeling initiatives in compliance with Corporate and local regulatory requirements. The incumbent will provide training, advice, and mentoring to affected cross-functional colleagues and within Labeling Operations, as appropriate, for labeling related procedures. The incumbent will provide functional support to label management as needed and assist/manage the overall operational activities of the DRA Labeling Operations Group to keep priorities in line with business goals. Duties & Responsibilities Independently communicates via established procedures with SLCI labeling services to revise and create artwork for various labeling components for assigned Boehringer Ingelheim marketed products. Ensures that timelines for revised artwork are adhered to in order to minimize impact on production. Interacts 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, provides training (using available training materials or creating new training materials) to affected cross-functional colleagues for labeling related procedures. Mentors the Boehringer Ingelheim RA Product Labeling Operations staff responsible for operational management in collaboration with Supervisor. Continuously identifies needs and develops and/or maintains local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements. Provides guidance, training, and technical expertise to labeling specialists and labeling managers for the preparation and approval of Structured Product Labeling (SPL) files. Collaborates with planning function to escalate and present requests to senior management to deviate from compliance implementation dates.
Operational Labeling Activities
Ensures labeling components for US late-stage development projects, new product launches, and post-marketing labeling revisions comply with Corporate Design guidelines and local regulations. Influences 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. Works closely with staff and project/product responsible DRA colleagues to plan, review, approve required labeling components for filing with the FDA and to identify/resolve issues associated with new product packaging and labeling development. When necessary, provides individual product support for these activities.
Maintain and Improve Regulatory Knowledge
Demonstrates excellent labeling regulations knowledge and seeks to improve knowledge on a continual basis to support US labeling responsibilities, processes, and management. Reviews regulatory developments to keep the company abreast of changes in the US regulatory environment impacting product labeling and packaging. Assists in training of DRA colleagues and individuals from other departments around package labeling generation and review. Maintains excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions. In collaboration with Supervisor, represents DRA Product Labeling Operations on local working groups.
Labeling Submissions to FDA
Prepares labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling Content, GSS, and RA Product Groups. Prepares leaf title documents and ensures all labeling files are eCTD compliant. Responsible for the labeling section of NDA Annual Reports.
Requirements
Associate Director: Bachelors degree with a focus in Biology or related field with eight to ten (810) years experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required, OR Masters degree with a focus in Biology or related field with six (6) years experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required. Minimum five (5) years labeling operations experience. Manager: Minimum B.S./B.A. degree with 58 years pharmaceutical experience in DRA or scientific discipline, with 2 years labeling experience preferred to understand labeling decisions; thorough knowledge of current FDA regulations, guidance documents, and initiatives; demonstrated ability to manage teams and projects; excellent proofreading/editing; and strong communication skills.
Eligibility Requirements
Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older
Compensation
This position offers a base salary typically between $115,000 and $222,000. It may be eligible for a role-specific bonus or other compensation elements. For an overview of benefits, please click here. Why Boehringer Ingelheim?
With us, you can develop your own path in a company that values diversity and inclusion and is committed to making millions of lives better. We support employee development and offer a culture that is independent, authentic, and bold. We provide programs to support health and wellbeing and opportunities to contribute to global accessibility to healthcare. Want to learn more? Visit https://www.boehringer-ingelheim.com #J-18808-Ljbffr