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.

Mgr Reg Affrs

Your tasks and responsibilities

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


  • Contribute to the development and implementation of regulatory strategies for new products in the US, enabling products to get to market as quickly as possible. Author and review regulatory documentation, checking for accuracy, scientific consistency,compliance to regulations and completeness. Clearly communicate recommendations to cross-functional teams. Research regulatory issues such as monograph status and labeling;
  • Participate in cross-functional and regulatory project teams working on developing product claims for labeling and promotion as well as commercialization of new products;
  • May act as company liaison to FDA for assigned products working closely with supervisor and senior colleagues. Assist with development of strategies to address FDA requests and requirements. Prepare and coordinate accurate and timely submissions to FDA, in particular assisting with preparation of US dossiers (IND/NDA/PMA/510k/30 day notices) and Annual Reports and Periodic Safety Reports;
  • Ensure regulatory compliance of marketed products. Review and approve promotional materials and labeling changes, following appropriate company processes. Contribute to the maintenance of US dossiers (IND/NDA/PMA/510k/30 day notices), including the preparation and submission of Annual Reports and Periodic Safety Reports;
  • Proactively identify regulatory issues/risks and design/execute mitigation plans;
  • Maintain current knowledge of regulations and industry environment and provide guidance on potential and evolving trends. May act as a company liaison to industry trade associations;
  • Create and manage strong network with key stakeholders such as marketing, legal, and other scientific personnel that facilitates collaboration;
  • The incumbent should be capable of performing these tasks with moderate supervision.


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:


Required Qualifications:


• A graduate degree in the life sciences (Ph.D., M.D., PharmD.or MS) or equivalent combination of education and experience;

• Experience to include Ph.D., M.D., or PharmD; or MS with a minimum of 2 years of Regulatory experience, or a Bachelor’s degree with at least 6 years’ of regulatory, or other relevant experience;

• Working understanding with OTC 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.

Your application

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. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.


Country: United States
Location: NJ-Whippany
Functional Area: [sap_fa_32]
Entry Level: 5