In Bayer's Consumer Health division, our vision is to make self-care for a better life a reality for billions of people around the world through everyday healthcare, primarily in the areas of allergy, analgesics (pain relief), cardiovascular risk prevention, cold and flu, gastrointestinal, and dietary supplements. Through our broad geographic footprint and portfolio of leading and trusted brands, people can get well, be well and stay well by taking charge of their everyday health, and the health of those they love. We touch billions of lives, helping provide them with safe, convenient and effective daily health solutions to treat minor illness and improve their lives.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Manager Regulatory Affairs, are to:
Provide regulatory support for new and existing products;
Be able to explore potential new products and claims, capitalizing on opportunities while not sacrificing regulatory compliance or consumer safety (success is measured by one's ability to negotiation win-win opportunities);
Be able to critically review significant quantities of written material (e.g. product labels, advertising copy) quickly and with attention to detail (success is measured primarily by accuracy, secondarily by timeliness);
Make decisions in labeling requirements, recommendations are incorporated into final labeling, which impact Brand group as well as Graphics and Change Control groups;
Follow appropriate regulatory pathways for new products, recommendations with impact, brand group with respect to potential business opportunity, clinical/Medical with respect to data necessary to support safety and efficacy of new product, product Development/Technical Operations with respect to data necessary to support premarket stability or post approval changes;
Support new claims to appropriateness of new claims or data necessary;
Give recommendations that will impact Brand group with respect to potential business opportunity, clinical/Medical with respect to data necessary to support appropriateness of new claims;
Review and suggest possible organization reaction to new or proposed legislation, recommendations can have a broad impact on new and existing products.
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 with at least four years of Regulatory experience or Master's with at least two years of Regulatory experience or Ph.D., M.D., or Phar.D with no Regulatory experience;
Have some familiarity working with FDA regulations;
Working understanding with FDA regulations;
Substantial experience with multitasking in a deadline controlled and highly regulated environment;
Ability to communicate effectively in English verbally and in writing;
Team and customer orientation;
Proficiency in MS Office;
Ability to accommodate changes and communicate them effectively;
Business savvy and commercial orientation.
Bayer is an Equal Opportunity Employer/Disabled/Veterans