Expiry Date: 07-09-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
My team and I would like to introduce to you an exciting new opportunity to join an EU medium sized Biotech that is now looking for an Associate Regulatory Director CMC Regulatory Affairs to join their team. The role is in a company where the global regulatory CMC leads and this career pathway, are based in the UK and Europe! This is rare in the UK. Even Managers and Senior Managers learn and develop on US and European submissions, so if you want to broaden your regional experiences, this is a good place to begin with!
POST-COVID: the official company policy is after Covid you can work from home 2-3 days a week as standard.
About the company:
The company’s vision underpins the ambition to transform lives of the people with rare and severe diseases for good and the focus is always on the patients. They are a research-based bio-pharmaceutical, with a good count of marketed products and one of the first to register a mAb in Europe but now are supporting multiple small molecules assets in Phase 2-3, for global development as well as preparing first submission.
They are very open to hiring both development and lifecycle CMC regulatory specialists with small molecule experience.
What is attractive about this opportunity:
At this role you will co-lead with the GRL global submissions for your assigned projects and take responsibility for the regulatory CMC support of small molecule assets throughout the lifecycle.
You will also lead on your own projects, you will help shape the strategy, planning and preparation of regional CMC documentation for your assigned regions and implement this strategy for CMC submissions as well as support and provide input to global submissions.
As the CMC expert, you will be accountable of aligning the GRA, technical and commercial teams as agreed with the Global Regulatory Lead to ensure effective communication of CMC strategy, risks, and overall plan.
Your experience and skills:
Our client is looking for individuals with a Life Sciences degree and around 7 years or more of experience in CMC, ideally the majority of which has been in the small molecules.
If you have only worked on IMPDs, or only on line extensions, for small molecules, this is valid, again, if you only have DS or only DP, this is valid, as long as it is with NCE’s.
Package and Benefits:
The Company is located on the M4 Corridor / West London / Bucks / Herts West area and the package they offer comprehends a very decent basic salary, with a 15% bonus with personal and company multipliers, stock options, company car and 25 days off a year!
To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to email@example.com. As I know the hiring manager, I will support you throughout the interview and on-boarding experience.
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