At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Manager Regulatory Affairs 

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Manager Regulatory Affairs, are to: 

• Provides regulatory support for new and existing products. Success is measured through:
• New Product/New Claim Review: must 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.
• Accuracy: must 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.
• Decisions made include:

• Labeling requirements: Recommendations are incorporated into final labeling, which impact Brand group as well as Graphics and Change Control groups.
• Appropriate regulatory pathways for new products: Recommendations with impact 1) Brand group with respect to potential business opportunity; 2) Clinical/Medical with respect to data necessary to support safety and efficacy of new product; 3) Product Development/Technical Operations with respect to data necessary to support premarket stability or post approval changes.
• Appropriateness of new claims or data necessary to support new claims:
• Recommendations will impact Brand group with respect to potential business opportunity;
• Clinical/Medical with respect to data necessary to support appropriateness of new claims: Recommendations will impact Brand group with respect to potential business opportunity;
• Clinical/Medical with respect to data necessary to support appropriateness of new claims.
• May be asked to 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

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor's degree;
• Requires some familiarity working with FDA regulations.
• Working understanding with FDA regulations is required
• 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
• Results orientation
• Business savvy and commercial orientation

Preferred Qualifications:

• Ph.D., M.D., or PharmD with no Regulatory experience required; or Master's with a minimum of 2 years of Regulatory experience; or a Bachelor's degree with a minimum of 4 years' of Regulatory experience.

Employees can expect to be paid a salary between $93148.00 - 139722.00.  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 10/22/2025