Regulatory Project Manager/Submissions Specialist
Posted on 27/07/15
Come Join Us
Position Regulatory Project Manager/Submissions Specialist
Location Sandwich, Kent, UK
Company Mylan Global Respiratory Group
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.
An exciting opportunity has arisen for a Regulatory Project Manager/Submissions Specialist within Mylan’s Respiratory Regulatory Centre of Excellence based in Sandwich, Kent.
Here’s how this role will help:
• You will work closely with the relevant cross-functional teams, to provide submissions expertise and support the preparation and submission for Mylan’s expanding portfolio of inhalation products, ensuring compliance with worldwide regulatory requirements at all stages of development through submission and to commercialization.
• Independently manage the regulatory submission and publishing activities in support of Mylan’s respiratory products, some of your responsibilities will include (but may not be limited to):
o Build of regulatory project plans to support global regulatory submissions spanning ANDA’s, NDA’s, MAA’s, IND’s and CTA’s
o Detailed knowledge and understanding of the submission and publishing requirements for FDA (and including OGD), EMEA, EU National Agencies, ROW Agencies
o Pro-actively contribute, participate and provide advice in regulatory and project team discussions on global respiratory product development and filing strategy
o Contribute to the establishment of Mylan external profile as a center of excellence for respiratory product development
• You will also be expected to contribute to the global regulatory submissions and publishing knowledge current, and contribute to the collective team expertise through; review of new and emerging regulatory guidance, attendance at appropriate conferences and cross industry data
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 healthcare. Here are the minimum qualifications for this position:
The qualifications and experience required for this position are:
• Extensive knowledge and proven track record of successfully managing the submission and publishing component of INDs, CTAs, MAAs, NDAs and ANDAs
• Demonstrated project management and interpersonal skills
• Broad functional knowledge of pharmaceutical sciences and a clear understanding of drug development
• The ideal candidate will be an enthusiastic, self-driven, and a highly motivated professional
If you want to be a 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 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 is an Equal Opportunity Employer.
To submit your application, please visit www.mylan.com/careers and select UK - you will then need to create a candidate profile to apply for the position.