Contract Regulatory Submissions Specialist (15-20 hours per week)

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 Submissions Specialist within Mylan’s Respiratory Regulatory Centre of Excellence based in Sandwich, Kent.

This role will help to manage submission ready training and publishing support for MGRG global submissions:

To provide:
• Mylan submission ready training to ANDA and MAA authors.
• Publishing support for ANDA’s, MAA’s, IND’s and CTA’s.

Main Accountabilities
• Manage the publishing/submission activities for ANDA, MAA and IND’s.
• Apply detailed knowledge and understanding of the US and EU submission requirements.
• Train the dossier authors on the regional submission ready requirements. Liaise with global and regional submission lines in order to ensure that the Mylan standard is represented

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:
• Demonstrated experience leading the submissions/publishing of regulatory applications.
• Demonstrated project management, interpersonal and leadership skills.
• Detailed knowledge of US and European pharmaceutical regulations and guidelines as they pertain to regulatory submissions/publishing.
• Detailed knowledge of document management systems such as Documentum
• Detailed understanding and practical experience of building submission ready/publishing MAA’s, CTAs NDA’s, ANDA’s, IND’s annual reports in eCTD, NeeS, and paper formats.


Why Mylan?
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 20,000 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 submit your CV/Covering letter via the apply online button: