Regulatory Affairs Labeling Operations Manager

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 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.

With minimal assistance from senior labeling management:

• Marketed products and Late Stage Development Projects - actively lead the execution and coordination of assigned operational labeling activities in conjunction with the assigned DRA product responsible colleagues in the DRA Product Groups and DRA Product Labeling Content Group. Ensure US marketed product labeling is compliant with Corporate Design and in a manner consistent with local regulations
• Develop subject matter expertise for labeling operational activities, including development/improvement of training and coaching tools
• Lead and/or participate on internal working groups as appropriate to develop and/or streamline business processes
• Based on organizational need supervise assigned RA Product Labeling Operations staff members
  
  
  

Duties & Responsibilities

• Actively lead the execution and coordination of labeling operational activities for assigned BIPI Marketed products. This may include but is not limited to, participation at Product Labeling Review Team meetings, internal labeling approval process as specified by best practices and office procedures, ensuring US marketed product labeling is compliant with Corporate Design and with local regulations
• Takes on delegated role for ad hoc project assignments where DRA Product Labeling operations representation is needed
• Independently communicate via established procedures with Graphics Office 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
• Collaborate with planning function to escalate and present requests to senior management to deviate from compliance implementation dates
• Attend SLCI job board and communicate upcoming labeling changes and submission strategies to impacted areas of the business. Responsible for ensuring KPIs assigned by
• the business are met
• Contribute to Annual Labeling Reviews: A) Ensure product labeling is reviewed on an annual basis and input is provided to PLRT for consideration at the annual label review B) Ensure summary of labeling changes is prepared in compliance with business timelines C)Provide sign off of annual labeling reports in absence of label management
• Provide guidance on annual reporting label requirements and ECTD structure to the labeling specialists
• Prepare, maintain, and update official BIPI labeling files (hard copy and electronic). Review and analyze labeling files for historical information and write reports for legal inquiries related to product labeling revision
• Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents, for example, SPL, MS Word files, Artwork needed for labeling submissions with contributing functions in other DRA groups such as DRA Product Labeling Content, DRA Operations, and DRA Product Groups
• Proofread labels/labeling for accuracy to confirm compliance with FDA requirements. Interact with Corporate Design Office as needed for US labeling changes to ensure consistency with design guidelines or requests for local deviations
• Proactively identify gaps in processes and scope; develop new standard operating procedures, lead implementation of continuous system improvements, maintain and enhance workflow tools used for electronic routing and approval of labeling change requests
  
  
  

Requirements

• Bachelors degree from an accredited institution preferred, with five (5) years of experience in the pharmaceutical industry, and a minimum of three (3) years of labeling experience; Or ten (10) years of experience in the pharmaceutical industry with a minimum of three (3) years of labeling experience. Required in order to be able to properly understand the implications of labeling decisions throughout the business and to manage work and possibly supervise employees in a dynamic environment
• One to three (1-3) years of leading employees and leading projects only
• Preferred supervisory experience in a dynamic environment with demonstrated ability to manage people and projects with changing priorities
• Must have exposure to package labeling development and implementation, including experience with drafting carton and container labeling and reviewing product labeling and compilation of supportive documentation to meet local compliance requirements
• No international experience required
• Must be able to lead specific strategy/planning activities for labeling implementation. When confronted with more complicated/novel matters, exercise sound judgement in escalating matters for management guidance
• Excellent communication and interpersonal skills in a strongly collaborative, multi- stakeholder environment
• Excellent verbal, written and presentation skills, with strong attention to detail
• Demonstrated people/project management with excellent planning and organization
• Demonstrated knowledge of regulatory labeling and compliance requirements, including technology trends
• High level ability to demonstrate agility in delivering results with fast and focused execution in a dynamic environment
• Knowledge of FDA regulations, guidances regarding labeling requirements, demonstrating high proficiency in interpretation of evolving requirements
• High level of experience and knowledge of Structured Product Labeling (SPL)
• Strong grammatical and proofreading/editing background required
• Excellent knowledge of applicable FDA regulations, guidelines and initiatives regarding the operational aspects of labeling. Abreast of regulatory requirements on labeling content
• Ability to evaluate the implication of regulatory requirements and internal process on labeling implementation to meet business and compliance objectives
• Excellent planning, organizing and decision-making capabilities
• Must be able to handle multiple priorities, resolve conflicts and solve problems with minimal supervision in a dynamic environment
• Must use sound judgement in elevating particularly complex matters to appropriate management for high level resolution
• Ability to work in a team environment with personnel within DRA as well as other functions and other external vendors
• Ability to perform diverse and complex tasks including experience with complex database applications used for monitoring labeling lifecycle
• High level computer literacy and able to adapt promptly to change
  
  
  

Desired Skills, Experience And Abilities

This position offers a base salary typically between $115,000 and $181,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here .

Our Company

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

Why Boehringer Ingelheim?

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

Want to learn more? Visit https://www.boehringer-ingelheim.com