• Associate Director / Manager , Regulatory Affairs Product Labeling Content Jobs in United States Of America - 25364096

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 3 - 4 Years
  • Posted : above 1 month

Job Description:

Associate Director / Manager, Regulatory Affairs Product Labeling Content - 1916649

Associate Director / Manager, RA Product Labeling Content

Candidate will be hired commensurate with the level

Associate Director, RA Product Labeling Content


Leads and manages the coordination of activities of labeling matters for assigned BIPI marketed products including Chairing Product Labeling Review Team (PLRT) meetings and providing substantial functional support for discussions (eg Annual Labeling Review, CCDS Updates, FDA letters, other ad hoc issues) and as part of PLRT, drafts/revises product labeling and compiles supportive documentation Ensures US marketed product labeling is in line with CCDS in a manner consistent with local regulations Brings PLRT proposals to PLC for discussion, review, and approval as required Provides input on any implications across other BIPI products Identifies and raises any issues affecting US labeling to PLC as a result of changing regulation/policy Supports late-stage development labeling for NCEs/NBEs and labeling supplements initiated by BI, in conjunction with the assigned RA Product Manager in the RA Product Groups

Continuously identifies needs and develops and/or maintains local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements The AD also provides training to affected cross-functional colleagues and within Labeling Content, as appropriate, for labeling related procedures Mentors BIPI RA Product Labeling Content staff members in labeling process and projects to build labeling expertise in collaboration with Supervisor Provides functional support to Supervisor as needed

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 Ingelheims high regard for our employees

Associate Director, RA Product Labeling Content

Manager, RA Product Labeling Content


Minimum BS/BA degree with 5-8 years pharmaceutical experience in Regulatory Affairs 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 labeling and compiling supportive documentation, and demonstrated competence in marketed product labeling maintenance
Capable of reviewing regulatory implications of non-clinical and clinical data to evaluate the regulatory implications for product labeling with substantial support and supervision
Detail-oriented, well organized and good planning skills Must be able to handle multiple priorities, resolve conflicts and solve problems with minimal supervision in a dynamic environment Must use sound judgment in elevating particularly complex matters to appropriate management for high level resolution
Excellent proofreading/editing skills are required
Excellent communication (verbal, writing, and presentation) skills necessary for interacting on a daily basis to address labeling content related matters with various personnel and line management both locally and globally
Ability to work in a team environment with personnel within RA as well as other functions

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

Who We Are

Job - Medicine

Primary Location - Americas-US-CT-Ridgefield

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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