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Director US Labeling & Registration
The Director US Labeling & Registration is responsible for the creation and maintenance of local labeling documents in accordance with the Company Core Data Sheet (CCDS) and associated documents for assigned Bayer Pharma products. In addition, manages the preparation and compilation of all US labeling documents relevant for registrations and supplements and manages the US implementation process, acting in close collaboration with global and local RA staff.
The position also contributes to the development of US product launch planning strategies and interacts with product life cycle teams to ensure the timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations and strategy to deliver high quality submission labeling. The position also facilitates strategic development of labeling by leading cross-functional labeling sub-teams through discussion and decision.
The ideal location for this role is in Whippany, NJ at Bayer's Corporate Headquarters. There may be a Residence based option for the right Candidate-prefer only people on the EST region.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Director US Labeling & Registration, are to:
Create and manages labeling in accordance with the US Code of Federal Regulations (CFR) for prescription products intended for US registration and ensures US package insert is consistent with the CCDS and adheres to the global corporate standards;Leads the Labeling Review Team which is responsible for the development, review and approval US labeling content for all prescription products intended for US registration and analyzes and evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required to implement;Provides strategic guidance and drives competitive US Labeling strategies through collaboration with cross-functional team member;Evaluates and communicates risks associated with labeling content and implementation strategies;Assess competitor labeling and understand precedents and opportunities for FDA interactions;Partners with Product Supply Labeling Development/artwork staff;Demonstrates, credibly embodies and role models VACC (Visionary, Architect, Catalyst, Coach) leadership being a(n):Visionary that guides teams in defining the outcomes to deliver on the mission.Catalyst that removes roadblocks to facilitate connections and collaboration.Architect that shapes a value creating system to unleash the passion and energy of our people.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
Minimum of a Bachelor’s Degree in life sciences is required; Direct experience with prescription drug labeling, drug importation, and establishment registration is required; Requires expert knowledge of and adherence to US regulations, especially as they apply to compliance, to support labeling-related regulatory activities. Scientific and technical expertise is an advantage. The incumbent should be able to follow tight timelines covering US procedures as they apply to labeling;Familiarity with medical terminology and knowledge of drug safety and the ability to transform medical terminology into patient friendly wording using layman terms;Solid knowledge of procedures in drug development and maintenance;Analytical regulatory skills are required;Must be able to manage multiple tasks simultaneously and management of deadlines;Applies our VACC leadership behaviors:Demonstrates high self-awareness as well as system awareness.Proactively asks for and gives feedback.Demonstrates strategic thinking as well as good business and external trends insights.Focuses on outcomes and defines and deliver highest pipeline, team, talent, and organizational impact outcomes.Collaborates with accountability and holds themselves and each other accountable in and across teams.Co-creates for customers: is close to the customer and co-creates solutions for their needs.Acts, learns fast and evolves: works in 90-days cycles, applies learnings fast and continually develops.Is their best self and includes others: respects differences, embraces inclusion and shows up as their best self.Command of English is required; ability to work within a global team framework and a multi-cultural environment is required; Must have well developed project management skills, including interpersonal skills;Excellent communication skills, verbal and written, are imperative.
Preferred Qualifications:
Ph.D., Pharm. D., or M.D. in life sciences (or equivalent experience) with a minimum of 8 years pharmaceutical industry experience (preferably within regulatory functions) or MS degree in life sciences with 10 years industry experience (preferably within regulatory functions) or bachelor’s degree in life sciences, with at least 12 years of pharmaceutical industry experience (preferably within regulatory functions), including 5 years of direct experience with prescription drug labeling, drug importation, and establishment registration or equivalent combination of education and experience is preferred;Experience interacting with health authorities is preferred.
Employees can expect to be paid a salary between $164,952 to $247,428. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
This posting will be available for application until at least: 8/13/25.
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YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.