Respiratory Regulatory CMC Manager/Senior Manager
Posted on 20/07/15
An exciting opportunity has arisen for a Respiratory Regulatory CMC Manager/Senior Manager, 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 expertise and support the preparation and execution of regulatory CMC strategies for Mylan’s expanding portfolio of inhalation products, ensuring compliance with worldwide regulatory requirements at all stages of development through commercialization.
- Providing high operational regulatory CMC input in support of Mylan’s respiratory products, some of your responsibilities will include (but may not be limited to):
- Development and management of regulatory CMC strategies, in line with overall product/project strategies.
- Pro-actively contribute, participate and provide advice in regulatory and project team discussions on global respiratory product development and filing strategy.
- Manage the preparation of high quality CMC (module 3) lifecycle regulatory documentation, including CTA, IND, ANDA, NDA and MAA.
- Coordinate regulatory activities cross functionally to ensure that the CMC documentation is submission ready in line with the project timelines.
- Undertake gap assessments of CMC data/documentation in support of business development activities.
- Contribute to regulatory agency meetings through the preparation of relevant materials and representation at meetings as appropriate.
- Contribute to the establishment of Mylan external profile as a center of excellence for respiratory product development.
- You will also be expected to keep your regulatory CMC knowledge current, and contribute to the collective Reg CMC team expertise through; review of new and emerging regulatory guidance, attendance at relevant 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 now 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:
- Minimum of a Bachelor’s Degree in a Life Sciences or related discipline
- Extensive knowledge and proven track record of successfully managing the preparation of CMC component of INDs, CTAs, MAAs, NDAs and ANDAs (in addition the preparation and management of post approval CMC documentation would be useful).
- Demonstrated project management and interpersonal skills.
- Broad functional knowledge of pharmaceutical sciences and a clear understanding of drug development or manufacturing/improvement processes.
- The ideal candidate will have experience on respiratory products and/or complex pharmaceutical forms. Experience/knowledge in medical devices and /or Quality management System is desirable.
- 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 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 visit www.mylan.com/careers and select UK - you will then need to create a candidate profile to apply for the position.