Regulatory Affairs Specialist CMC

Mylan Laboratories Inc. Morgantown , WV 26502

Posted 2 months ago

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

  • Must possess knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations, various FDA Guidance's for Industry, along with knowledge of the regulatory process pertaining to drug

development, registration, review and approval would be desirable.

  • Must possess strong written and verbal communication skills, interpersonal skills, management skills, strong work ethic, consensus gathering skills and a working knowledge of Microsoft Office including Work, Excel and Lotus Notes.

  • Position functions autonomously and consults with departmental management on an as-needed basis.

  • Minimum of a bachelor's degree (or equivalent) and 0-2 years of experience. Minimum of a Bachelor of Arts / Bachelor of Science Degree in Science or health related field plus a minimum of 2 years of experience in the pharmaceutical industry or PharmD preferred. However, a combination of experience and/or education will be taken into consideration

  • Ability to read and interpret complex business and/or technical documents.

  • Ability to write comprehensive reports and detailed business correspondence.

  • Ability to work with groups of people such as other departments and communicate known concepts.

  • Ability to present to a group of departments.

  • Ability to calculate figures and amounts as necessary, such as percentages, proportions, volume, weight per unit volume, etc. Above average mathematical skills required.

  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

  • Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.

  • Normal office situation.

Why Mylan?

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.

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Regulatory Affairs Specialist CMC

Mylan Laboratories Inc.