In Bayer”s Pharmaceuticals division, we focus on researching, developing and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.
We are looking for dynamic individuals to join the Bayer team who are interested in pursuing a career in Regulatory Affairs. Candidates must be available for a 3-month assignment at Bayer”s Whippany, New Jersey site during the timeframes indicated in the job qualifications section.
As an Intern within the Regulatory Affairs department, the incumbent will gain valuable work experience in the healthcare industry while working with regulatory professionals on various projects to learn about the role of regulatory affairs in drug development and product registration as well as the regulatory landscape. Along with on the job training, candidates will be assigned a mentor and expected to deliver a project at the end of the internship. Regulatory Affairs works with Health Authorities in many countries around the world, giving you the opportunity to work in a truly global workplace. The current regulatory environment is changing rapidly and we are looking for future leaders who are interested in working with Health Authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) the China Food and Drug Administration (CFDA).
Within this role, opportunities may exist within Regulatory Affairs Operations, Labeling or Submissions.
The primary responsibilities of this role, Regulatory Affairs Intern, Undergraduate, are to:
- Maintain database to ensure proper tracking and recording of key submission activities involving INDs, NDAs and Periodic Safety Reports;
- Assist with scanning and indexing activities in support of document archival processes;
- Work with the Global Regulatory Strategists, assist with the coordination and compilation of various technical and clinical report documentation in support of pending submissions;
- Work with Global Regulatory Operations, assist with quality control checks of eCTD documentation to ensure the integrity of technical data links and eCTD lifecycle management;
- Work with Global Regulatory CMC (Chemistry, Manufacturing and Controls), assist with maintenance tasks relating to regulatory compliance activities involving manufacturing change controls and document archiving;
- Work with Global Labeling and Advertising, assist with general maintenance activities involving tracking of label changes, database support management and coordination of promotional material for submission;
- Assist with general organizational activities involving regulatory files, tracking spreadsheets, and other support documents as needed.
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:
- Currently enrolled in an undergraduate (Bachelors) program at a full-time accredited U.S. college or University;
- Majoring in health sciences, engineering, pharmaceuticals, policy administration, public health, life sciences, medicine, pre-med or a related field;
- Be a sophomore or higher;
- Be a full-time continuing student (i.e. enrolled in school for the next term – not graduating in Spring 2021);
- Strong written and communication skills.
- Available to work during one of the two following timeframes at 40 hours/week :
- May 17th, 2021 – August 6th, 2021
- June 14th, 2021 – September 3rd, 2021
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.