Boehringer Ingelheim
Associate Director/Manager, Product Labeling (Hybrid)
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Associate Director/Manager, Product Labeling (Hybrid)
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Description
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 company's success. We support our employees with a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our compensation and benefit programs reflect Boehringer Ingelheim 's high regard for our employees.
Position Overview
The Associate Director, DRA Product Labeling will lead and manage the coordination of operational activities of labeling/packaging matters for assigned Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) marketed products. This includes label compliance reviews, development and maintenance of packaging components, and liaison with the corporate design office, graphic offices, and production sites to ensure timely implementation in line with local regulations and corporate objectives. The role supports 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 incumbent will participate as a PLRT member contributing to the compliance and grammatical accuracy of labeling content and may present packaging concepts when required. The position also focuses on identifying opportunities to improve efficiency and compliance in labeling initiatives.
Responsibilities
Independently communicate with labeling services to revise and create artwork for labeling components for assigned BIPI marketed products
Ensure timelines for revised artwork are met to minimize impact on production
Collaborate with Corporate Design Office for US labeling changes to maintain design guideline consistency
Provide training to cross-functional colleagues on labeling procedures
Mentor DRA Product Labeling Operations staff and support labeling management
Develop and maintain local procedures to support labeling initiatives in compliance with corporate and regulatory requirements
Provide guidance and technical expertise on Structured Product Labeling (SPL) files
Advise on process improvements to support labeling initiatives in compliance with regulatory requirements
Operational Labeling Activities
Manage labeling components for US late-stage development, new product launches, and post-marketing labeling revisions in compliance with corporate guidelines and local regulations
Influence key labeling operational activities to achieve timely reviews/approvals with internal customers and FDA
Collaborate with RA colleagues to plan, review, and approve labeling components for filing (e.g., SPL, Artwork, Word files) and resolve packaging and labeling issues
Provide product-specific support as needed
Regulatory Knowledge & Training
Demonstrate robust knowledge of labeling regulations and continually update knowledge to support US labeling responsibilities
Track regulatory developments affecting labeling and packaging
Assist in training DRA colleagues and other departments on package labeling generation and review
Maintain knowledge of SOPs, guidelines, and working instructions
Represent DRA Product Labeling Operations in local working groups
Submissions to FDA
Prepare labeling documents for regulatory submissions with contributing functions from other departments
Prepare leaf titles and ensure all labeling files are eCTD compliant
Manage the labeling section of NDA Annual Reports
Requirements
Associate Director:
Bachelor’s degree in Biology or related field with 8–10 years of pharmaceutical industry experience in Regulatory Affairs or a related scientific discipline; or Master’s degree with 6 years of experience
Minimum five (5) years of labeling operations experience
Manager:
Minimum B.S./B.A. with 5–8 years of pharmaceutical experience in DRA or scientific discipline; 2 years labeling experience preferred
Experience drafting and reviewing product package labeling and preparing label submission documents; demonstrated competence in labeling maintenance
Thorough knowledge of current FDA regulations and guidance on content and use of package labeling
Ability to manage teams and projects with changing priorities; strong proofreading/editing skills
Excellent communication skills for daily interactions with personnel and management globally
Independent work capability with good judgment and ability to collaborate cross-functionally
Strong written, verbal, and presentation skills with attention to detail
Ability to deliver results in a dynamic environment
Eligibility
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 and may be eligible for a bonus or other compensation elements. For an overview of benefits, please see the company site.
Why Boehringer Ingelheim?
We offer development opportunities in a culture that values diversity and fosters a healthy, collaborative workplace. We support work-life balance and provide programs for health and wellbeing.
For more information, visit: https://www.boehringer-ingelheim.com
Note : This description reflects the responsibilities and qualifications of the role and does not include extraneous postings or unrelated job listings.
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Description
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 company's success. We support our employees with a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our compensation and benefit programs reflect Boehringer Ingelheim 's high regard for our employees.
Position Overview
The Associate Director, DRA Product Labeling will lead and manage the coordination of operational activities of labeling/packaging matters for assigned Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) marketed products. This includes label compliance reviews, development and maintenance of packaging components, and liaison with the corporate design office, graphic offices, and production sites to ensure timely implementation in line with local regulations and corporate objectives. The role supports 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 incumbent will participate as a PLRT member contributing to the compliance and grammatical accuracy of labeling content and may present packaging concepts when required. The position also focuses on identifying opportunities to improve efficiency and compliance in labeling initiatives.
Responsibilities
Independently communicate with labeling services to revise and create artwork for labeling components for assigned BIPI marketed products
Ensure timelines for revised artwork are met to minimize impact on production
Collaborate with Corporate Design Office for US labeling changes to maintain design guideline consistency
Provide training to cross-functional colleagues on labeling procedures
Mentor DRA Product Labeling Operations staff and support labeling management
Develop and maintain local procedures to support labeling initiatives in compliance with corporate and regulatory requirements
Provide guidance and technical expertise on Structured Product Labeling (SPL) files
Advise on process improvements to support labeling initiatives in compliance with regulatory requirements
Operational Labeling Activities
Manage labeling components for US late-stage development, new product launches, and post-marketing labeling revisions in compliance with corporate guidelines and local regulations
Influence key labeling operational activities to achieve timely reviews/approvals with internal customers and FDA
Collaborate with RA colleagues to plan, review, and approve labeling components for filing (e.g., SPL, Artwork, Word files) and resolve packaging and labeling issues
Provide product-specific support as needed
Regulatory Knowledge & Training
Demonstrate robust knowledge of labeling regulations and continually update knowledge to support US labeling responsibilities
Track regulatory developments affecting labeling and packaging
Assist in training DRA colleagues and other departments on package labeling generation and review
Maintain knowledge of SOPs, guidelines, and working instructions
Represent DRA Product Labeling Operations in local working groups
Submissions to FDA
Prepare labeling documents for regulatory submissions with contributing functions from other departments
Prepare leaf titles and ensure all labeling files are eCTD compliant
Manage the labeling section of NDA Annual Reports
Requirements
Associate Director:
Bachelor’s degree in Biology or related field with 8–10 years of pharmaceutical industry experience in Regulatory Affairs or a related scientific discipline; or Master’s degree with 6 years of experience
Minimum five (5) years of labeling operations experience
Manager:
Minimum B.S./B.A. with 5–8 years of pharmaceutical experience in DRA or scientific discipline; 2 years labeling experience preferred
Experience drafting and reviewing product package labeling and preparing label submission documents; demonstrated competence in labeling maintenance
Thorough knowledge of current FDA regulations and guidance on content and use of package labeling
Ability to manage teams and projects with changing priorities; strong proofreading/editing skills
Excellent communication skills for daily interactions with personnel and management globally
Independent work capability with good judgment and ability to collaborate cross-functionally
Strong written, verbal, and presentation skills with attention to detail
Ability to deliver results in a dynamic environment
Eligibility
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 and may be eligible for a bonus or other compensation elements. For an overview of benefits, please see the company site.
Why Boehringer Ingelheim?
We offer development opportunities in a culture that values diversity and fosters a healthy, collaborative workplace. We support work-life balance and provide programs for health and wellbeing.
For more information, visit: https://www.boehringer-ingelheim.com
Note : This description reflects the responsibilities and qualifications of the role and does not include extraneous postings or unrelated job listings.
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