Expiry Date: 31-03-2021
Category Regulatory Affairs
Job Type: Full Time
Technical Regulatory & Quality Policy & Intelligence Head *** US DC or East Coast
This role is open to individuals working with Regulators, Industry Associations, Certification Bodies and within Industry. Please read below!
Note: My client has put in place a hiring process during COVID, and a digital on-boarding process, to enable a smooth selection and on-boarding process for the next few months. Drug testing and some background checking will be suspended until later. Initially you will be on-boarded and working from home until office bound travel is allowable!
Location: This role can be based in the 3 different US-based, East Coast locations including Washington DC. Also this role can be based in Switzerland. The USA locations and Switzerland are supported for US-based candidates. The role, if needed, comes with a strong relocation package. This is a global role, covering all the core markets so eventually, there will be some travel for conferences, association meetings and for global LT meetings (post-COVID!).
About My Client
You will want to work with a company which has a distinct pedigree! My client is a well-known successful bio-/pharma with a run of successes for their patients across many therapy areas, and a distinct R&D footprint in both small and large molecules of many varieties.
They were one of the first companies to register a mAb and although this is nearly 15 years ago, they have a similar number of firsts, for ATMPs across a range of molecule types! Their portfolio includes several high-performing patient assets and they have worked diligently to gain a profitability per employee most companies would be glad to see.
This role reports into an individual I have worked with for more than 10 years, whom has a track record in developing regulatory CMC functions for 2 SMEs, and has in their formative years supported NMEs in development and major filings with a Top 3 Pharma. They are a fair and pragmatic leader with a flair for mentoring and leading highly capable, high-performing individuals.
The company are well presented in industry on wider regulatory policy and CMC sciences forums managed by experts and peers within the greater MSAT / CMC & Global Tech Ops organization. So this is a ‘First in Role’ hire, to act as the conduit and bring together policy advocacy for a range of CMC regulatory related topics for Advocacy, internally with the wider Bio-/Pharma Dev and GTO organization folks, and the external policy forums, for a company which relishes pioneering science, not just in the clinic, but also in the molecule development sciences and manufacturing sites.
About Your Background
So I am seeking an individual who has helped to shape CMC Regulatory and Quality Policy, and has a passion for new technologies and new thinking, so you may have grown with PAT/RTRT and QbD or might have come in later with ATMPs and Gene or Cell Therapies or both.
You may be working within industry with a Bio-Pharma or a major Regulator, or industry Trade Association or Certification Body but will have make inroads into Policy one way or another, directly or indirectly as part of your role. You will feel comfortable working with MSAT and Commercial Manufacturing on their topics, and supporting internal stakeholders to develop their advocacy positions, which you will help to relay through Association’s committees, joint agency / industry working parties, and through conference speaking and participation. You may be a luminary or flag holder for this area, and now want to work in a company which has the pipeline to apply the future of manufacturing sciences now.
Most of all you will feel comfortable understanding the landscape for RA CMC and Quality Policies and how a leading biotech can gain leverage and a bigger voice through good science backed by innovation in Manufacturing Sciences and Technology.
You will know who you are because you will resonate with many of the key points. I have bandwidth on grading and the package is commensurate with the visibility of the role.
Package & Bonus
The role comes with a strong incentives package including bonus, stock options and RSUs. My client will consider some stock buyout within reason for the right person.
To apply for this role, please press the red “Apply for position”, or contact me, Matt Greig, on my US number 908-332-9157, or if you are dialling from Europe, please call my UK number on +44 207 801 3386 - I take calls from 7 am Eastern US time to 4.30 pm daily as well as Saturday and Sunday AMs.
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