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. Here's how this role will help:
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:
Minimum of a Bachelor's degree (or equivalent) and 5-6 years of relevant regulatory experience and supervisory skills. However, a combination of experience and/or education will be taken into consideration.
Must possess expert-level knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA guidance for Industry and have the ability to interpret these to apply to Mylan procedures. Must also possess expert-level knowledge of the regulatory process pertaining to drug development, registration, review and approval. Must possess knowledge of Mylan’s approach with regards to interactions with the FDA.
Must possess strong analytical, organization, technical writing, and communication skills. Must have the ability to multi-task and have meticulous attention to detail. Must possess strong computer skills and working knowledge of Microsoft Office Suite, Documentum, and Lotus Notes.
Must be able to manage various projects and employees in order to meet submission deadlines.
Position functions autonomously. Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
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.
Proficiency in speaking, comprehending, reading and writing English is required.