About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Join our Regulatory Professional Development Program and propel your career in a global setting.
The position has been designed to provide entry-level experience in key regulatory disciplines within the company Essential Health - dossier preparation and filing, lifecycle management, labeling, regulatory operations, technology transfer and other manufacturing strategies.
The successful candidate(s) will rotate through a two-year, full-time program designed to provide a breadth of regulatory exposure across the Essential Health portfolio - Biosimilars, Legacy the company Brands, Combination Products, Generics and Sterile Injectibles.
The successful candidate(s) will be based out of our New York, New York or Lake Forest, IL office.
With oversight, collaborates with other functional areas to obtain documentation for regulatory purposes. Seeks expert advice and technical support as required. Ensures accuracy and completeness of all information.
Assembles, prepares and submits original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements and guidelines.
Prepares responses to action letters and other agency requests.
Assists manager in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products.
Evaluates manufacturing and labeling changes for regulatory impact with guidance.
- PharmD or PhD candidates graduating in Winter 2016/2017 or Spring 2017
- GPA of (or equivalent to) 3.0 or higher
- Scientific background via formal education
- Strong communication and interpersonal skills
- Demonstrated leadership through extracurricular activities
- Interested in pursuing a career in Regulatory Affairs
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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