Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Sr Manager Local Labeling & Registration
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Manager Local Labeling and Registration, are to:
Create and manage labeling in accordance with the US Code of Federal Regulations (CFR), including Structured Product Labeling (SPL), if applicable, for assigned products intended for U.S. registration;
Ensure U.S. labeling is consistent with the Company Core Datasheet and adheres to the global corporate standards;
Support drug-device labeling projects, as needed;
Lead the U.S. Labeling Review Team, which is responsible for the development, review and approval of U.S. labeling content for all assigned products intended for U.S. registration;
Analyze and evaluate requests for new or revised labeling initiated by FDA or Bayer and manage action required to implement with Product Supply;
Partner with Product Supply artwork staff and Change Management;
Ensure compliance with FDA regulations pertaining to site establishment registrations of manufacturing, testing and labeling facilities;
Support, as a backup, import requirements involving clinical supplies and marketed products are adhered to, including coordinating with FDA and/or import agents the release of any product or drug compound held in detention by U.S. importation authorities;
Be responsible for the planning and coordination of FDA user fee payments to FDA to include site registration, product, and application fees.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Bachelor’s degree in life sciences, with at least six years of pharmaceutical industry experience or Master of Science in life sciences with at least four years of pharmaceutical industry experience or Ph.D., Pharm. D., or M.D. in life sciences (or equivalent field) with at least two years of pharmaceutical industry experience;
Two years of direct experience with FDA-regulated labeling and establishment registration;
Have solid knowledge of the FDA-regulated industry;
Have solid knowledge of the pharmaceutical drug industry, the company’s business practices and processes and products;
Expert knowledge of and adherence to U.S. regulations, especially as they apply to compliance, to support FDA-regulated labeling-related regulatory activities;
Be able to follow tight timelines covering U.S. procedures as they apply to labeling;
Be familiar with medical terminology and also have some knowledge of drug safety;
Be able to transform medical terminology into patient friendly wording using layman terms;
Be able to successfully negotiate with stakeholders of the process in different departments, including the divisions of FDA responsible for labeling;
Be able to absorb large amounts of information efficiently, give sound judgments and act professionally in order to manage difficult problems effectively;
Analytical regulatory skills;
Be able to focus and be target-oriented in a complex scientific / technical environment;
Be able to focus on multiple issues/projects simultaneously and have the ability to organize and direct diverse activities in a changing environment, often under time pressure;
Ability to work in English;
Ability to work within a global team framework and a multicultural environment;
Have well developed project management skills, including interpersonal skills;
Excellent communication skills, verbal and written;
Willing to travel domestic and international less than 10%;
Be proficient in computer skills.
Ph.D., Pharm. D., or M.D. in life sciences with pharmaceutical industry experience;
Experience within regulatory functions;
Experience with FDA-regulated labeling (prescription drug);
Knowledge of drug importation requirements;
Expert knowledge of and adherence to U.S. regulations, especially as they apply to compliance, to support FDA-regulated (prescription drug);
Scientific and technical expertise;
Has a solid knowledge of company policies and procedures in drug development and maintenance;
Have skills and experience in dealing with Health Authorities;
Command of German.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. 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.