Manager Global Regulatory Affairs

21 Aug, 2020

Jobs

Manager Global Regulatory Affairs

Bayer
Whippany, NJ

YOUR TASKS AND RESPONSIBILITIES

 

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

 

  • Contribute to development and implementation of global regulatory strategies for assigned projects and ensure proper and timely new product registration in identified markets;
  • Review regulatory documentation, checking for accuracy, scientific consistency, compliance to regulations and completeness;
  • Research regulatory issues;
  • Ensure that product dossiers are properly prepared, maintained and accessible;
  • Ensure that all registration data are entered into proper data management systems;
  • Provide support to local affiliates with strategy formulation and registration requirements for assigned products;
  • May interact with Health Authorities, working closely with supervisor and senior colleagues;
  • Participate in cross-functional teams regulatory project teams;
  • Manage preparation of registration dossiers related to assigned products;
  • Proactively identify and track regulatory activities and/or issues and risks and design/execute mitigation plans with support and alignment of manager/leadership;
  • Liaise with Drug Safety and Medical to assist local countries in substantiating claims;
  • Provide regulatory expertise to and oversee work of Regulatory Specialists supporting the assigned product or as assigned by I&D Unit Regulatory Strategy Lead;
  • Maintain current knowledge of regulations and industry environment to and provide guidance on potential and evolving trends;
  • Regularly report status measures to Regulatory Strategy Management and appropriate stakeholders;
  • 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:

 

  • Bachelor’s degree with at least four years of Regulatory experience or Master’s degree with at least two years of Regulatory experience or Ph.D., M.D. or Pharm.D with no Regulatory experience;
  • Working understanding of U.S., EU and/or LATAM regulatory procedures;
  • Substantial experience with multi-tasking 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.

 

This role can be located in any of the following areas:

  • Whippany, New Jersey, USA
  • Mississauga, Ontario, Canada
  • São Paulo, Brazil
  • Bogotá, Colombia
  • Mexico City, Mexico

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. 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.

Learn more here

Job posted: 2020-08-21