Should you be interested in the above position and wish to apply, please send your application with your CV,

quoting the above reference number, to our recruitment team at recruitment@ctcon.ch

CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK Tel.: +44 207 193 9972 www.ctcresourcing.com info@ctcon.ch

Providing Flexible Resourcing Solutions CTC Resourcing Solutions, founded 1997, is a pan-European specialist staffing organisation with offices in London, Basel and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing For a key client, we are currently looking for a:

Director Regulatory Affairs Reference Number: 46-885-DRA-W Type of placement: Permanent Location: Oxfordshire, UK Our client is an entrepreneurial drug discovery and drug development company focused on breakthrough treatments for unmet needs across a range of disease areas. Located in Oxfordshire and with compounds currently in early phase trials, our client has recently strategically refocused the company on the development of its high value clinical stage assets. The objective is to add value to its programmes by advancing them through to important clinical milestones at which time the Company will seek to partner the programmes. As part of this strategy the company is seeking to hire an experienced Director Regulatory Affairs who will lead the development and implementation of regulatory strategies to ensure the optimum global approval for clinical development candidates. Purpose: The Director Regulatory Affairs is a visible and influential position requiring leadership, oversight and operational accountability for regulatory affairs strategy and execution. In the short term, this includes being hands-on in regulatory activities in support of clinical programmes. Longer term you will be accountable for developing a strategy that will form the basis of Marketing Authorization Applications (MAA). Main Responsibilities:

Ensures alignment of regulatory strategy with corporate objectives.

Develops and implements strategies for the timely submission and approval of pre-clinical submissions, clinical trial applications and advises on key development strategy as the products progress to marketing authorisation.

Recommends and executes strategies for the earliest possible approvals of Clinical Trial Applications (CTAs)

Provides expertise in translating regulatory requirements into practical, workable development plans.

Prepares for, organises and oversees the appropriate internal and external clinical audits and inspections.

Performs regulatory review of labelling, manufacturing, and communications documents, and clinical protocols for regulatory compliance and recommends appropriate changes where required.

Should you be interested in the above position and wish to apply, please send your application with your CV,

quoting the above reference number, to our recruitment team at recruitment@ctcon.ch

CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK Tel.: +44 207 193 9972 www.ctcresourcing.com info@ctcon.ch

Monitors and improves tracking/control systems.

Regulatory intelligence role, providing a critical analysis of the relevant legislation and guidance including risks.

Attends and acts as the regulatory representative at relevant project meetings.

Interacts with and acts as the Company representative to the relevant US, European and international regulatory agencies.

Qualifications and Experience:

Educated to degree level or equivalent in a relevant scientific field

Extensive experience in regulatory processes in industry setting.

Demonstrable experience of leading a regulatory-filing process and activities for Phase I and II trials toward later Marketing Authorization Application (MAA)

Extensive knowledge of drug development regulations and guidelines

Experience of interacting with European and other international regulatory authorities to ensure development plans are in line with current regulatory requirements

Experience of regulatory development in a biotech environment

Knowledge of US regulatory requirements

Our offer:

Competitive basic salary

Discretionary Bonus

Benefits package o Contributory pension o Life assurance o Private health o Share option plan

28 days holiday