Bayer Manager Global Regulatory Affairs Regional Strategist in Whippany, New Jersey

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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.

Apply online

Manager Global Regulatory Affairs Regional Strategist

Your tasks and responsibilities

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

  • Work with local and lead Global Regulatory Strategist (GRS) on Regulatory Strategy for assigned Medical Device Projects or Drug Development Projects by contributing to assess regulatory strategy options on a regional/local basis;

  • Act as an interface between Bayer and the local Health Authorities (HAs);

  • Participate in the preparations for meetings or teleconferences with the HAs, and assist with the development of the briefing documents for the meetings or teleconferences for the assigned projects;

  • Work with local and lead GRS and supervisor to compile and submit Investigative New Drug (IND) and/or clinical trial applications to ensure timely start of the clinical trials for the assigned development products;

  • Work with local and lead GRS and supervisor to develop submission materials for the local HAs, guide the review process, and check for accuracy, scientific consistency, compliance to the local HA regulations and completeness of the submission;

  • Support the local and lead GRS in the Global Regulatory Team(s) to provide input for all phases of drug development for investigational products, licensed projects and or medical devices, and contribute to the development of the Global Regulatory Plan(s), particularly with regard to addressing local HA requirements and the needs of the local market;

  • Collect and review competitor information, local HA guidelines/guidance and precedence;

  • Enter submission materials, and relevant data and documents into the appropriate regulatory affairs databases;

  • Complete assigned projects/tasks in high quality within defined timelines;

  • Contribute to the development and implementation of regulatory strategies.

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:

Who you are

  • Advanced degree (Ph.D., D.V.M. or Pharm.D. in life sciences) with at least 1 year of experience in biomedical research or development activities, OR M.S. degree with at least 3 years’ of experience in biomedical research or development activities, OR B.S. degree with at least 5 years’ of experience in biomedical research or development activities;

  • Good communication (verbal and written), analytical and project management skills;

  • The ability to work within a global team framework and multicultural environment.

Preferred Qualifications:

  • Prior regulatory affairs experience;

  • Some familiarity with local HA regulations and regulatory guidance/guidelines (e.g. U.S. FDA or EMA), to support product development of drugs and medical devices and regulatory filings;

  • Basic therapeutic knowledge and understanding of clinical development.

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