Associate Director / Manager, Regulatory Affairs Product Labeling Content
US-BI Pharma/BI USA
 Ridgefield, CT

Associate Director / Manager, Regulatory Affairs Product Labeling Content

Candidate will be hired commensurate with the level.

Associate Director, RA Product Labeling Content

Description:

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 (e.g. 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 Ingelheim's high regard for our employees.

Associate Director, RA Product Labeling Content

Duties & Responsibilities:

  • Independently chair the meetings of the Product Label Review Teams (PLRT) for each marketed product and provide substantial functional support for discussions such as the Annual Labeling Review, Company Core Data Sheet (CCDS) Updates, and other ad hoc issues as they occur (e.g. FDA requests for labeling changes). As part of PLRT, draft/revise product labeling and compile supportive documentation. Ensure that each marketed product’s labeling is in line with the company's CCDS in a manner consistent with the local health authority's regulations and guidelines. Assure timely availability of preparatory documentation before the meetings, identification of issues for discussion, and prepare meeting minutes following the meeting, as well as follow up on outstanding issues for complete resolution.
  • Bring PLRT proposals to Product Labeling Committee (PLC) for discussion, review, and approval as required. Identify and raise any issues affecting labeling to PLC as a result of changing FDA regulation or policy. Provide input on the implications of any of the PLRT's labeling proposals for other BIPI products. Provide functional support to Supervisor as needed and assist PLC Secretary with preparing for PLC meetings, including compilation of agenda topics and supporting documentation, identification of PLRT participants, etc. as necessary.
  • Interact with Global Labeling (GL) before major US labeling changes to ensure consistency with company core labeling, or the need for a revision to the core labeling. From a labeling perspective, advice on suitability of CCDS proposals for implementation in the US, provide impact assessment on US labeling, and function as a liaison to the PLRT to facilitate US-specific labeling feedback and needs into Global RA sub-teams.
  • In collaboration with Supervisor and upon Supervisor request, provide training (using available training materials or create new training materials) to affected cross-functional colleagues, as appropriate, for labeling related procedures.
  • Mentor BIPI RA Product Labeling Content staff members in labeling process and projects to build labeling expertise in collaboration with Supervisor.
  • Continuously identify needs and develop and/or maintain local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements.
  • Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling Operations, RA Operations, and RA Product Groups. Review labeling section of NDA Annual Reports, PADERs, PBRERs.
  • Maintain and improve Regulatory Professional Knowledge: demonstrate excellent labeling regulations knowledge. Seek to improve knowledge on a continual basis to support US labeling responsibilities, processes, and management. Review regulatory developments to keep the company abreast of changes in the US regulatory environment impacting product labeling. Assist in training of RA colleagues and individuals from other departments in the area of labeling generation and review. Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions. In collaboration with Supervisor, represent RA Product Labeling Content on local working groups.
  • Support 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.
  • Serve as back-up to other PLRT Chairs for other marketed products when needed.

Associate Director, RA Product Labeling Content

Requirements:

  • Requires eight (8) to ten (10) years’ experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline, with Bachelor’s degree from an accredited institution OR six (6) years with Master’s degree from an accredited institution.
  • Minimum five (5) years labeling experience in order to be able to properly understand the implications of labeling decisions throughout the business.
  • Four (4) to six (6) years project management experience
  • Must have demonstrated strong experience drafting, editing, and reviewing product labeling and compiling supportive documentation, as well as 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 minimal support and supervision.
  • Requires thorough knowledge of current FDA regulations, guidances, and initiatives regarding content and use of labeling; demonstrated ability to manage teams and projects with changing priorities in a dynamic environment is required
  • Excellent proofreading/editing skills are required
  • Excellent communication skills (verbal, writing and presentation) necessary for interacting on a daily basis to address labeling content 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 judgment for independent decision making vs. upper management involvement.
  • Ability to work in a team environment with personnel within RA as well as other functions.
  • Requires proficient knowledge of US regulatory environment in product labeling requirements to ensure product labeling is maintained in a timely and accurate manner to comply with FDA regulations and to communicate essential product information to the marketplace.
  • Labeling implementation should be managed to ensure that all regulatory/legal requirements are in place to ensure BI is compliant with obligations towards patient safety, product integrity, and company credibility.
  • Requires demonstrated strong ability to independently manage teams and projects with changing priorities in a dynamic environment.

Associate Director, RA Product Labeling Content

Desired Skills, Experience and Abilities:

  • In a leadership role, must be able to lead specific strategy/planning activities for labeling implementation. When confronted with more complicated/novel matters, exercise sound judgment in escalating matters for management guidance.

Manager, RA Product Labeling Content

Description:

With minimal assistance from senior labeling management:

Manage coordination of activities of labeling matters for assigned BIPI marketed products, including chairing Product Labeling Review Team (PLRT) meetings associated with the Annual Labeling Review, Corporate CCDS compliance, and labeling activities initiated by BIPI or FDA and as part of PLRT, draft/revise product labeling and compile supportive documentation. Also serve as back-up with some supervision to other PLRT Chairs for other products.

Support late-stage development labeling for NCEs/NBEs and labeling supplements initiated by BI, in conjunction with the assigned DRA product manager in the DRA Product Groups.

Bring PLRT proposals to PLC for discussion, review, and approval as required. Provide input on any implications across other BIPI products. Identify and raise any issues affecting US labeling to PLC as a result of changing regulation/policy.

Ensure US marketed product labeling is in line with CCDS in a manner consistent with local regulations.

Manager, RA Product Labeling Content

Duties & Responsibilities:

  • With minimal assistance from senior labeling management, chair the meetings of the Product Label Review Teams (PLRT) for assigned marketed product and provide functional support for discussions such as the Annual Labeling Review, CCDS Updates, and other ad hoc issues as they occur (e.g. FDA requests for labeling changes).
  • As part of PLRT, draft/revise product labeling and compile supportive documentation. Ensure that each marketed product’s labeling is in line with the company's CCDS in a manner consistent with the local health authority's regulations and guidelines.
  • Assure timely availability of preparatory documentation before the meetings, identification of issues for discussion, and prepare meeting minutes following the meeting, as well as follow up on outstanding issues for complete resolution. Also, bring PLRT proposals to Product Labeling Committee (PLC) for discussion, review, and approval as required.
  • Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents needed for regulatory submissions with contributing functions in other departments such as RA Product Labeling Operations, RA Operations, and RA Product Groups. Review labeling section of periodic reports such as NDA Annual Reports, PADERs, PBRERs, etc.
  • Demonstrate proficient and consistently evolving labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting regulations and guidances, particularly in the area of product labeling.
  • Review regulatory developments with RA Product Labeling Groups and keep BI abreast of changes in the US regulatory environment impacting product labeling.
  • Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions.
  • Interact with Global Labeling (GL) for potential CCDS updates/proposals: With support from senior labeling management,from a labeling perspective,advise on suitability of CCDS proposals for implementation in the US, provide impact assessment on US labeling, and function as a liaison to the PLRT to facilitate US-specific labeling feedback and needs into Global RA sub-teams.
  • Ensure appropriate preparation and escalation of applicable discussion points to Labeling Content Group Leader and/or Management in ILC preparation meetings.
  • Provide back-up operational support to PLRT Chairs for other marketed products when needed.

Manager, RA Product Labeling Content

Requirements:

  • Minimum B.S./B.A. 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:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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