Expiry Date: 05-09-2022
Categories Biotech, Manufacturing / Production, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Our client is a medium-sized global pharmaceutical company, with a good count of marketed products and one of the first to register a mAb in Europe some time back, but they have built on this, and are currently registering worldwide a future blockbuster, as well as having in Phase 3 2 more mAbs, soon to be in readout. Overall, the teams are supporting a mix of multiple mAbs and recombinants in Phase 1-3 for global development as well as preparing BLA/MAAs as well as the first round of variations, hence they are looking for Senior Manager or Associate Director with solid CMC bio experience, ideally some DS as well as DP, for at a minimum, the EU Centralised Procedure (if you have US experience or International with your EU, even better).
At the same time, they offer you the opportunity to grow in the Regs CMC ladder to the Global CMC RA strategist role, and be acknowledged on your achievements within a friendly and rewarding environment, in a team led by an experienced Global Head and LT, who have actually filed mAbs in their formative years. Most of the time, as you know, big-sized pharma companies come across as a nice place to be, but perhaps, you might feel silo’ed or overlooked, this is a medium sized biotech, which will give you more visibility.
On another note, doing good work and having more impact, doesn’t depend only on yourself. Feeling good at work, makes you more focused, enthusiastic and reliable to develop yourself on each step of the way, right? My client is offering this type of environment, with a very good package! Also you can be based mostly at home, or work in the office, they offer the hybrid model.
At this role, you will be responsible for covering the global regulatory affairs and new dosage forms submissions throughout all product life-cycle phases (phase 1-3 MAA, BLA, NDA) and post-approval for mAbs. For the AD grade, you will be the RA CMC lead on your own projects, or you will work in a bigger team supporting and leading a much bigger MAA program.
You will sometimes re-author and review M2.x/3 the based including new submissions IMPD or MAA/BLA subs and together with the Global CMC Regulatory Lead, provide responses for HA interactions and Responses to Questions for CMC matters. The site is based in the West London / Middlx / Berkshire area, easily reached from as far as Amersham to the north, St Albans, Reading or Hampshire.
Your Experience & Skills
Our client is looking for individuals with a Life Sciences degree and around <> 5 years or more of experience in RA CMC, ideally the majority of which has been in the biologicals. If you have only worked on IMPDs, or only line extensions but not first MAAs, for biologicals, this is also valid.
The company offer a good package at Senior Manager and Associate Director level, at AD level the roles come with Stock, all roles come with a bonus of 10-15%, plus bens incl. a car!
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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