Head of CMC Regulatory Excellence ** Mainland Europe *** Relocation provided *** Sr Director grade *** Nascent Oncology Biotech

Reference: 48776

Expiry Date: 13-03-2024

Category Biotech

Salary: Competitive

Job Type: Full Time


Apply for position

Job Description

This role is not based in Belgium but comes with a relocation package which can be acted upon this summer or earlier. The relocation package is generous and the site is located outside in the suburbs of a European Capital city with good transport links, and a high-quality lifestyle and housing.

This SME and R&D-based Biotech organization is rapidly growing its pipeline and has expanded its turnover by around 20% in the last two years, from the new product launches it has been rolling out, and has 15 or so NMEs in the pipeline, with 3 or so in line extension development. The organization is established, stable and has a long history in drug development but started focusing on Oncology in the recent past. The company are rapidly transforming and this role is part of that transformation.

As part of and as a key member if the Regulatory CMC Leadership team, the successful candidate will provide regulatory excellence to the CMC Regulatory department, manufacturing, QA and therapy regulatory, and will have 4 main deliverables, with a focus on small molecules primarily and large molecules as well, you will provide Policy and Intel, High Impact Taskforce Management, Triage and internal Expert, and as an Agent for change.

The role is for someone who is hands-on and has spent a lot of time in CMC Regulatory at a project level, in clinical development for RA CMC and further line extensions development, and has a good understanding of global as well as the EU and international regulatory environment and would like to “slowly” grow into a policy and intelligence professional, without losing your hands-on capabilities.

The line manager is ex regulator, and has a lot of Biotech and Pharma experience and has led filings with his teams to approvals. This individual sees this role as pivotal, because you will help develop the CMC regulatory organization into a top flight team with bandwidth, and work to give the organization a seat at the table in policy and advocacy, while supporting cross department, regulatory intelligence and knowledge sharing for critical development and lifecycle pathways, the “how to’s” and co-provide expertise to individuals and teams, on anything pertaining to CMC Regulatory.

The company is growing and has over achieved its mid-term goals and is now focused on leveraging its assets to build both the pipeline and diversity of its modalities (currently, incl. RNAs, NCEs, mAbs and proteins).

To apply for this role, you must be willing to relocate to the location by end of Summer 2024. Please call in for the exact location and details, and I will support you every step of the way.

The package includes 3 levels of bonus, as well as a generous salary at Senior Director levels and there are incentives to join available for the right compelling and successful candidate.

Please contact me, Matt Greig, on email to matt@advtalent.com quoting Ref2024/12, enclosing a full CV and contact number.