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Boehringer Ingelheim · 1 day ago

Associate Director/Manager, Product Labeling (Hybrid)

Ridgefield, CT

Full-time

Hybrid

Lead/Staff, Director/Executive

$115K/yr - $222K/yr

5+ years exp

Boehringer Ingelheim is a global leader in the pharmaceutical industry, and they are seeking an Associate Director/Manager for Product Labeling. This role involves leading and managing operational activities related to labeling and packaging for marketed products, ensuring compliance with regulations and corporate guidelines while also providing training and support to cross-functional teams.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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

Qualification

Labeling operations experienceFDA regulations knowledgeRegulatory Affairs experienceBiology degreeProject managementProofreading/editing skillsAgility in executionCommunicationTeam collaborationAttention to detail

Required

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

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

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

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

Benefits

Role specific variable or performance based bonus

Other compensation elements

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees