The document advertises a position for a Regulatory Affairs Manager at a drug development company located in Oxfordshire, UK. The position requires leadership and oversight of regulatory strategies to ensure global approval of clinical development candidates. Responsibilities include developing regulatory strategies, submitting clinical trial applications, interacting with regulatory agencies, and preparing for audits. The ideal candidate has a scientific degree, extensive regulatory experience in the pharmaceutical industry, experience leading regulatory filings for clinical trials, and knowledge of international drug regulations and guidelines. The compensation package includes salary, bonus, pension, insurance, share options, and 28 days of paid time off.

1. 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:
Regulatory Affairs Manager
Reference Number: 46-885-RAM-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 Regulatory Affairs Manager who will lead the development and implementation of
regulatory strategies to ensure the optimum global approval for clinical development candidates.
Purpose:
The Regulatory Affairs Manager 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.

2. 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