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Head of Regulatory Affairs - Wales

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Head of Regulatory Affairs
Our client is a small but growing start up company in Biotechnology, more specfically in stem cell research and development
With unique and pioneering technologies already delivering therapeutic product candidates to the clinic.
It's primary objective is the development of novel stem cell therapies targeting areas
of significant unmet or poorly met medical need.
All of the company's current operations - R & D, Manufacturing Development,
Clinical, Regulatory, Corporate etc. are based in the UK. Manufacturing of clinical material is currently outsourced to
It is the intention of the company to move its base to South Wales within the next 12
months. Its new home will be a brand new, custom-built facility that will house,
amongst others, its highly respected R & D Group and a new state of the art
manufacturing facility to produce material for the planned Phase III trial through to
market authorization and commercial supply.
The current headcount at the client is approximately 30 employees, but this is anticipated to
rise during 2015 as the new manufacturing facility comes on line.
The Role
As the Head of Regulatory Affairs, you will be accountable for all aspects of the
Company's regulatory activities across all of its programmes, ensuring compliance
with regulatory requirements and timely submissions in line with Company objectives.
Key accountabilities:
- Formulate and recommend the Company's regulatory strategy for each
therapeutic programme (territory, tactics, etc.) As a member of the Company's
management team provide key input to the planning of goals and timelines,
with specific regard to regulatory activities
- As a hands-on manager, draft, review and submit regulatory documents and
interacting with regulators thereafter (INDs, CTAs, amendments, ODDs, MAs
etc.) Write briefing books SOPs etc
- Forward plan timelines, resources and costs for the full range of projects and
tasks then manage them in order to meet company priorities. Select and
manage third party contractors of appropriate capability in order to cope with
peak work loads.
- Provide oversights and review of in-house regulatory documentation (SOP's,
policies, protocols, etc.) and interaction with the Quality function to ensure all
regulatory requirements are met.
- Act as main point of contact with regulatory and ethical review authorities
globally - be responsible for maintaining and developing constructive working
relationships with those bodies.( Will require international travel for key
regulatory meetings)
- Maintain up to date knowledge of developments in the regulation of ATMPs-
Keep the management team abreast of all regulatory developments that may
affect the business.
- Develop strategies to influence regulators in the forward development of
regulations for these cutting edge products to ensure an appropriate risk
based approach and participate in consultations and lobbying
Required qualifications
· Life Sciences Degree
· Extensive experience in the management of Regulatory affairs.
Essential Experience
· Thorough knowledge and hands-on experience of all aspects of managing
Regulatory Affairs within a Pharma/Biotech company to gain clinical trial
approvals in novel or leading edge drugs/technology
· Experience in advising the flexible, risk based approach for early and clinical
development of ATMPs/biologics
· Experience at senior management level. Have the ability to communicate with
full range of people/professionals (medical/research/contract labs &
manufacturers etc etc).
· Experience in handling an uneven workload through the selection and coordination
of appropriate contract resource
Desirable Experience
· Familiarity with stem cell development or gene therapy
· Previous interaction and contacts within EMA and CAT
· Experience (or at least good knowledge of regulations (US and EU)) for Cells
and Tissues procurement/storage.
· Experience in product licensing and gaining market approval
· Understanding/ experience of pharmacovigilance requirements relating to
clinical trials.
Please apply directly on our website
or contact Steven D'hont, our KSR consultant at 2 .
Région: Pays de Galles
Type: Fixe
Catégorie: Stratégie & Management;
Publiée le: 12/08/14
Taux d'occupation: Plein temps (100%)
Numéro du poste: JO-1408-13672
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