Senior Director, Head of Regulatory CMC Respiratory and Biosimilars

For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a Difference 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:Provide high quality strategic and operational regulatory CMC leadership to Mylan's respiratory and biosimilars. The ideal candidate will have a proven track record of working at a senior level within regulatory CMC across a range of products/portfolios. * Establish and provide strategic leadership and oversight of the Regulatory CMC function within Mylan's Respiratory and Biosimilar divisions. * Accountable for the development and execution of RCMC strategies and plans across Mylan's Respiratory and Biosimilar portfolio in line with company and project goals. * Contributes at a senior level across workstreams and with Mylan's partners on relevant products to ensure development of aligned strategies and timely submission and approval of pre-and post-approval regulatory dossiers. * Maintains oversight of regulatory CMC documentation prepared & submitted to regulatory authorities in support of product development and maintenance activities. * Oversee the growth and development of individuals within RCMC function, ensuring flexibility within the group to deliver portfolio to budget and requisite quality. * Adherence to all applicable policies and procedures, including those relating to EHS, GMP, GCP, Quality and Compliance, consistent with the role and any associated responsibilities, including people management where applicable. * Perform other duties as assigned consistent with the grade of the role 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: * Regulatory experience with demonstrated project management, interpersonal and leadership skills * Broad experience in regulatory product development. Detailed understanding of relevant regulatory guidelines & their interpretation in the development of new and generic products * Broad functional knowledge of pharmaceutical sciences and a clear understanding of drug development or manufacturing/improvement processes. * Extensive knowledge and practical experience of building CMC component of MAA's, NDA's and ANDA's. * Broad experience of leading, negotiating and liaising with global Health Authorities on CMC technical and strategic matters. * Experienced and confident in liaising with external pharmaceutical forums. * Effective verbal and written communication skills * Be prepared for occasional business travel/ willingness to travel 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 Mylan.com 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.