Director, Regulatory Affairs - CMC Biologics

Employer
Compass Life Sciences
Location
Essex (GB)
Salary
£80,000 - £120,000 DOE
Closing date
25 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Director, Regulatory Affairs - CMC Biologics   
Location - Essex     
Salary - £80,000 - £120,000 DOE
    
      
Compass Life Sciences have partnered with an industry leading and highly regarded expert Regulatory Consultancy who are continuing a journey of exceptional business growth.  As a business, they typically prefer to recruit from within, however this is a rare occasion where they are looking to bring in talent and experience from outside the organisation to bolster their Regulatory offering from a senior leadership level.     
      
The Role     
      
Our client is looking for an experienced and confident Regulatory Affairs professional who is comfortable being very client facing.  You will provide top level development stage advice to internal staff and to your clients for a vast range of biologics and/or Cell and Gene therapy programmes. You will speak with knowledge and assurance about client programmes and provide a large range of services.       
      
Key Responsibilities and Duties   
 

  • Provide world-class advice across a range of biologics and/or cell and gene therapy product types
  • Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
  • Provide development related strategy for a broad range of programmes
  • Provide Biologics and/or ATMP advice and dossier support for US based programmes
  • Lead EMA procedures including orphan applications, PIPs and MAAs
  • Provide expert EU regulatory strategy
  • Regulatory lead and point of contact for national agency and EMA interactions
  • Provide direct line management and matrix team based leadership where needed
  • High level of client focus and accountability
  • Assist with Business Development activities by taking part in new prospective client-lead discussions

 
Required Experience     
 

  • Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
  • Extensive and broad European regulatory affairs experience with Biologics and/or ATMPs
  • Biologics/ATMP regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
  • Demonstrable experience in orphan applications and PIPs
  • Strong understanding of the regulatory environment including guidelines
  • Ability to lead team members in a matrix management environment
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Confident speaker about regulatory challenges in the clinical development of biological and next generation technologies, and approaches to finding solutions.
  • Ideally our client is looking for significantly more experience than highlighted above working within Regulatory Affairs, with experience of Regulatory Authority interactions and US FDA facing experience.       

         
Why apply?      
      
Our client is growing.  This means that there will be opportunities to get involved in a wide range of initiatives and projects, significantly increasing the exposure you will get to a broad range of projects. Given the size of the organisation, you will be expected to get involved in a range of initiatives broader than your job description, which will further furnish you with new skills and experiences that will boost your CV.      
      
If you are interested in learning more about this role, or would like a confidential exploratory conversation, contact Brandon Kersley today at bkersley@compassltd.co.uk, or call +44 (0)2392 316039 or +44 (0)7802624497.     
      
Compass Associates Ltd trading as Compass Life Sciences is acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation. 

Compass Life Sciences was formed in 2018 by veteran recruitment professionals. Candid conversations with Investors and clients identified a demand for highly knowledgeable, experienced, quality-based recruitment solutions within the sector that offered a genuine, consultative service.

Our capabilities have grown in line with our team’s headcount; and we now serve a wide range of key specialisms including R&D, Clinical Research, Commercial Operations, Data & Bioinformatics, Regulatory Affairs and Medical Affairs. We have been consistently commended for offering the highest levels of knowledge-based recruitment solutions to both candidates and clients.

We believe that the future of recruitment is firmly rooted in ingrained partnerships, where a more proactive and strategic relationship is important. As Compass Life Sciences continues to move forward, we will endeavour to provide the highest quality, valued solutions in all our relationships.

Differentiated by quality and knowledge, Compass Life Sciences has been born out of the desire to raise the standards of Life Sciences recruitment in the UK and Global markets.

As a team, we are proud to be able to evidence experience working in the Pharmaceutical, Biotech and Supplier & Vendor industries, ranging from University Placement Years, through to onsite Talent Acquisition employment, which has provided our fundamental understanding of the specialisms we recruit both for, and into

Contact Us
  • Admiral House
  • 8a, High Street
  • Cosham
  • PO6 3BZ
  • United Kingdom
  • 02392 384555
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