Senior Regulatory Affairs Manager
- South East
- Permanent
- Drug Safety / Pharmacovigilance
This vacancy has now expired
Our biotech client, with manufacturing facilities just outside London, is currently investing significantly in their manufacturing programme. This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. The site is easily reachable by two major airports and has excellent transport links throughout.
The client is currently seeking the expertise of a Senior Regulatory Affairs Manager due to their rapidly growing team!
In this role you will be responsible for the line management of a team of permanent staff members, helping to manage their goals, objectives and training needs. You will oversee all licensing activities throughout the product range. Along with this you will ensure proper process and systems are in place to manage all regulatory activities related to drug licenses.
You will have the following experience/qualifications:
- 7-10 years experience within Regulatory Affairs
- Demonstratable experience with managing business critical and complex drug development projects and licensing activities
- Broad knowledge of regulatory filing strategies
- Demonstrable team leadership skills
- Project Management skills are desirable
- Substantial experience in obtaining and maintaining product licenses worldwide and obtaining clinical trial authorisations in key markets (EU, US )
- Substantial knowledge of current drug regulations in key markets (US, EU,)
- Substantial experience of dealing and negotiating directly with Health Authorities in key markets (EU, US)
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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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