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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
The Associate Director, DRA Product Labeling will lead and manage the coordination of operational activities of labeling/packaging matters for assigned BIPI 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 AD, DRA Product Labeling will participate as a PLRT member contributing to the compliance and grammatical aspects of the content of labeling. Additionally, when required, the incumbent will present packaging concepts for consideration. The position holder will continuously evaluate innovative opportunities to improve efficiency and execution of process to support labeling initiatives in compliance with Corporate and local regulatory requirements.
The AD, DRA Product Labeling Operations 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.

REQUIREMENTS

Associate Director:

• Bachelor’s degree with a focus in Biology or related field with eight to ten (8-10) years’ experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required OR Master’s 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 to be able to properly understand the implications of labeling decisions throughout the business

Manager:
Minimum B.S./B.A. degree with 5-8 years pharmaceutical experience in DRA or scientific discipline, with 2 years labeling experience preferred in order to be able to properly understand the implications of labeling decisions throughout the business.
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- Experience drafting and reviewing product package labeling and preparing label submission documents and demonstrated competence in marketed product labeling maintenance.
- Requires thorough knowledge of current FDA regulations, guidance’s, and initiatives regarding content and use of package labeling.
- Demonstrated ability to manage teams and projects with changing priorities is required; excellent proofreading/editing skills are required.
- Excellent communication skills necessary for interacting daily to address labeling operational related matters with various personnel and line management both locally and globally.
- High level of independence for day-to-day activities with little to no supervision.
- Excellent judgement for independent decision making vs. upper management involvement.
- Ability to work in a team environment with personnel within RA as well as other functions.
- Excellent verbal, written and presentation skills, with strong attention to detail.
- High level ability to demonstrate agility in delivering results with fast and focused execution in a dynamic environment.Continuously evaluates innovative opportunities to improve efficiency and execution of process.
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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.

Maintain and improve Regulatory Professional Knowledge –

• Demonstrates excellent labeling regulations knowledge.
• 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

• Independently communicates via established procedures with SLCI responsible or labeling services to revise and create artwork for various labeling components for assigned BIPI marketed products.
• Ensures that timelines for revised artwork are adhered to as 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 and upon Supervisor request, provides training (using available training materials or create new training materials) to affected cross-functional colleagues, as appropriate, for labeling related procedures.
• Mentors the BIPI 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.

Independently manages Operational Labeling Activities –

• Ensures labeling components for BIPI 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 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, provides individual product support for these activities.

Maintain and improve Regulatory Professional Knowledge –

• Demonstrates excellent labeling regulations knowledge.
• 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 ensure all labeling files are ECTD compliant.
• Responsible for the labeling section of NDA Annual Reports.