Manager/Senior Manager, Regulatory CMC
Posted on 16/03/17
Come Join Us
Position: Manager/Senior Manager, Regulatory CMC Location: Sandwich, Kent, UK Contract: Contractor position (initial period of 6 months) 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.
A contract position has arisen within the Mylan Global Respiratory Group Regulatory team, for a Regulatory CMC Manager/Senior Manager to provide Regulatory CMC support to the team.
The successful candidate will:
- Contribute/Lead the preparation of Regulatory CMC documentation for Mylan’s global respiratory portfolio
- Interface with key internal stakeholders including Pharm Sciences and Devices Teams, QA and Commercial Manufacturing, Regulatory Strategy and Project Management.
- Provide support to the MGRG Regulatory leadership to develop tactical plans for respiratory products as assigned.
Main accountabilities will include:
- Leading in the preparation of CMC documentation for clinical trial and registration submissions for MGRG’s respiratory portfolio across global territories
- Ensuring alignment with regulations, guidelines and Mylan’s policies and procedures.
- Working with contributors to develop tactical plans to ensure delivery
- Authoring high quality documentation directly as appropriate
- Co-ordination of authors/SMEs to deliver documentation as required
- Management of the review and approval process.
- Supporting the preparation of responses to Health Authority questions, working with project teams, SMEs and external suppliers as required.
- Planning and management of deliverables to timelines and communication of progress to MGRG seniors.
- Conducting GAP analysis of regulatory CMC documentation as required
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 and essential functions for this position:
• Excellent communication skills, written and verbal, and experience with Microsoft Word and Microsoft Excel. • Previous experience working in Regulatory CMC or related area within Pharmaceutical Industry • Experience in preparation of Regulatory CMC documentation in support of registrations in US and/or EU • Science degree • Experience of using Documentum and MS software packages • Proficiency in speaking, comprehending, reading and writing English is required
• Experience in preparation of Regulatory CMC documentation in support of registrations in ROW countries • Experience in preparation of Regulatory CMC documentation in support of clinical trial submissions • Regulatory CMC experience of developing respiratory products in the R & D environment.
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 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 is an Equal Opportunity Employer.
To submit your application, please submit your CV/Covering letter to email@example.com – stating “Regulatory CMC Contractor” in the subject line.