Job title: Regulatory Affairs Associate Director - EU Oncology Launch - Home-based
A mid-sized Pharmaceutical company with multiple offices across the UK are seeking a Regulatory Strategy Associate Director. This role will lead an MAA with the EMA with a filing taking place in Spring 2022. The role will be responsible for presenting to the Global Molecule Team and the commercial team and making strategic decisions around the product.
This role is working on a new drug launch. There are also a couple of pipeline products that are coming in the next 1-2 years so it is a true development role. This role will mentor a Senior Manager and sit within a team of 5 people.
- Supervising activities that include planning and co-ordination of the writing and reviewing all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).
- Leads functional/department multi-disciplinary teams in complex, business critical projects to establish regulatory strategies for commercial products, late, and early-stage development programs.
- Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
- Work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
- Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals
- Bachelors or Masters or advanced degree in a scientific discipline
- Proven track record of effective collaboration with regulatory agencies
- Experience with maintenance of regulatory authorisations in at least one region
- Experience with supporting a project with development activities in at least two regions
Salary and benefits:
A highly competitive salary, annual bonus, car allowance, initial stock reward and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org