Manager, Regulatory Affairs-Nutritionals

Whippany, NJ, United States
May 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
Your tasks and responsibilities

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

  • Contribute to the development and implementation of regulatory strategies for new products in the U.S., 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;
  • Act as a company liaison to the Food and Drug Administration (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;
  • 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;
  • Be capable of performing 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 degree in the life sciences (Bachelor, M.S, PharmD, Ph.D., M.D.) or equivalent combination of education and experience.
  • PharmD, Ph.D. M.D. with a minimum of two years of Regulatory experience, or M.S degree with at least four years' of Regulatory experience, or Bachelor's degree with at least six years' of Regulatory, or other relevant experience;
  • Working understanding with Over the Counter (OTC) 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 Microsoft 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