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Specialist, Regulatory Affairs CMC

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POST DATE 9/3/2016
END DATE 11/11/2016

Mylan Inc Morgantown, WV

Mylan Inc
Morgantown, WV
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
Bachelors Degree


FOR US, ITS A MISSION At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats easy. If you are a doer and have a passion for serving others, we want to talk to you.

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Heres how this role will help:

* Prepare FDA required Annual Reports for Abbreviated New Drug Applications by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to the application, and tracking progress of their preparation. This duty includes the review of documents, interacting with multiple departments (QA, QC, Manufacturing Purchasing, R&D, etc.) which provide information and documentation, utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements.

* Assist departmental management in keeping product marketing applications current by requesting revisions to technical documentation as part of the Annual Report preparation process.

* Manage the preparation and review of supplements to ANDAs for management review. Manage data and information including monitoring submission schedules for adherence to deadlines for Manufacturing & Supply chain.

* Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation.

* Provide a critical detailed review of technical documentation including product labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications, etc. prior to FDA submission.

* Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, etc.) for planned changes.

* Track ANDA commitments made to FDA to ensure that these commitments are honored and reported in a timely manner.

* Assist departmental management in the preparation, review and submission of ANDAs, amendments and supplements to product marketing applications.

* Assist in the preparation and review of Technical Transfer packages and ensure compliance with the registered application.

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:

* Minimum of a Bachelor's degree (or equivalent) and 0-2 years of experience. Minimum of a 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.

* Must possess knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations, various FDA Guidances 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.

* 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.

* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

* 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.

* The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

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 30,000 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.

Job Posting: Sep 2, 2016, 9:22:59 AM
Unposting Date: Ongoing.