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.
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
- 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.
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 email@example.com, 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.