Expiry Date: 20-07-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
My team and I would like to present you a really good opportunity to join a mid-sized EU Biotech as a Senior Manager or Manager in Regulatory CMC. This is a strong opportunity because they have the Global Regulatory CMC ladder, in Europe not the USA, and even Managers and Senior Managers get the opportunity to work on BLA and US IND submissions!
POST-COVID: the official company policy is after Covid you can work from home 3 to 4 days a week as standard. There is a courtesy bus from the train station, and ample parking.
About the Client:
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 mAbs and recombinants in Ph 1-3, for global development as well as preparing first BLA/MAAs.
They are very open to hiring both development and lifecycle CMC regulatory specialists with biologicals experience.
What you will do:
At this role you will be responsible for covering the global regulatory affairs and medical devices submissions throughout all product life-cycle phases (ph 1-3 MAA, BLA, NDA) and post-approval for mAb’s.
As you will be the RA CMC 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 both CMC and medical devices submissions will rely on you.
You will author and review M2.x/3 the based on the CMC RA plans, including new submissions; represent the CMC GRA together with the global CMC regulatory lead as well as leading and/or provide input to HA interactions on CMC.
Your experience and skills:
Our client is looking for individuals with a Life Sciences degree and around <> 5 years or more of experience in CMC, ideally the majority of which has been in the biologicals.
If you have only worked on IMPDs, or only on line extensions, for biologicals, this is valid, again, if you only have DS or only DP, this is valid, as long as it is with bio, which includes vaccines, recombinants or mAbs.
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 10% bonus with personal and company multipliers 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 firstname.lastname@example.org. I will support you throughout the interview and on-boarding experience.
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