Regulatory Affairs Labeling Operations Manager

10+ years

Not Disclosed

Remote, USA

10 Feb. 13, 2025

Job Description

Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Labeling Operations Manager

Job ID: 18558
Location: Ridgefield, CT, United States
Job Function: Regulatory Affairs
Career Level: Experienced Professionals
Working Time: Full-Time
Job Flexibility: Hybrid

Position Overview

As a Regulatory Affairs Labeling Operations Manager at Boehringer Ingelheim, you will lead the execution and coordination of labeling activities for marketed products and late-stage development projects. This role will allow you to contribute directly to the company's success by ensuring compliance with corporate design and local regulations for US marketed product labeling.

You will also develop subject matter expertise in labeling operations, lead operational activities, and participate in various cross-functional working groups. Additionally, this position offers an opportunity for leadership, as you may supervise RA Product Labeling Operations staff.

Key Responsibilities

Labeling Operational Activities:
- Lead the execution and coordination of labeling activities for assigned marketed products.
- Participate in Product Labeling Review Team (PLRT) meetings and internal labeling approval processes.
- Ensure product labeling is compliant with Corporate Design and local regulations.
Collaboration and Communication:
- Collaborate with the Graphics Office to revise and create artwork for labeling components.
- Communicate timelines for revised artwork to minimize production delays.
- Liaise with various business units and ensure KPIs are met.
Annual Labeling Reviews & Reporting:
- Ensure product labeling is reviewed on an annual basis, and provide input for consideration.
- Contribute to the preparation of labeling reports and SPL submissions.
Process Improvement:
- Identify gaps in labeling processes and lead the implementation of system improvements.
- Develop and implement standard operating procedures (SOPs) for labeling operations.
Regulatory Submissions:
- Coordinate preparation of regulatory labeling documents for FDA submissions, such as SPL and artwork files.
- Ensure consistency with FDA regulations and compliance with labeling guidelines.

Qualifications & Requirements

Education:
- Bachelor’s degree from an accredited institution (preferred).
Experience:
- Minimum of 5 years of experience in the pharmaceutical industry with at least 3 years of labeling experience.
- Alternatively, 10 years of industry experience with 3 years in labeling.
Leadership Experience:
- 1-3 years of experience leading employees and managing projects in a dynamic environment.
Labeling Expertise:
- Exposure to package labeling development, including drafting carton and container labeling.
- Knowledge of FDA regulations and experience with Structured Product Labeling (SPL).
Skills:
- Strong communication and interpersonal skills in a collaborative environment.
- Excellent attention to detail, proofreading, and editing skills.
- Proficiency in planning, organizing, and decision-making.
- Ability to work in a team environment and handle multiple priorities.

Compensation & Benefits

Base Salary: Typically between $115,000 and $181,000, depending on experience.
Bonus & Benefits: The position may include a performance-based bonus and other compensation elements.
Comprehensive benefits include healthcare, life insurance, and access to various employee development opportunities.

About Boehringer Ingelheim

Boehringer Ingelheim is a family-owned company established in 1885, committed to developing innovative therapies for humans and animals. With over 52,000 employees globally, we foster a diverse and inclusive culture, encouraging collaboration, growth, and innovation.

Why Boehringer Ingelheim?

Growth Opportunities: We offer a respectful, friendly working environment, with a focus on learning and development.
Innovation: Join us in a company driven by innovation and the desire to improve lives.
Diversity & Inclusion: We prioritize diversity, embracing different perspectives to enhance our workplace and communities.

Ready to apply?
Click the “Apply Now” button to start the application process.

For more information about our career opportunities, visit Boehringer Ingelheim Careers.

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Regulatory Affairs Labeling Operations Manager

Job Description

Job Title: Regulatory Affairs Labeling Operations Manager

Position Overview

Key Responsibilities

Qualifications & Requirements

Compensation & Benefits

About Boehringer Ingelheim

Why Boehringer Ingelheim?

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