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:

Senior Associate Regulatory Affairs - Development

Reference Number: 893094-WType of placement: PermanentLocation: Marlow, Buckinghamshire, UK

Our client is the fastest growing global ophthalmic company and holds leadership positions in other specialty areas including neurosciences, medical aesthetics and medical dermatology. In 2012, the company invested nearly $1 billion in R&D, a rate above industry standard, in one of the most robust product pipelines in the specialty pharmaceutical market. The same year approximately 13,000 patients enrolled in 32 clinical trials in with 50% enrolment outside of the United States.

Purpose:

• Supports the implementation of regulatory strategy in EMEA and provides regulatory support for the registration and post-licensing activities of medicinal products.

• Develops and maintains knowledge of EU regulatory procedures.• Contributes to the European Regulatory Affairs team.• Builds and maintains relationships with Regulatory and other staff within and outside the

region to ensure effective communication and efficient implementation of regulatory activities.

Main Responsibilities:

Development

• Provide appropriate EU regulatory input to project teams via the Global Liaison and Global Regulatory Teams

• Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.

• (With some supervision) supports the communication of regulatory strategy in support of new product registration, in line with commercial objectives.

• Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.

• Ensures effective handover to Product Lifecycle team, lifecycle management and maintenance.

• Together with the regulatory staff “in country”, develops an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation.

Product Lifecycle Management

• With supervision, plans and implements regulatory activities in support of lifecycle management (renewals) and CMC maintenance in the region.

• Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.

• Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during lifecycle management and maintenance.

• Together with the regulatory staff “in country”, develops an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation of the company.

• Establishes relationships with “in country” teams and global regulatory teams thereby ensuring local RA activities are in line with global and regional business priorities.

• With supervision, manages marketed product labelling, to ensure alignment with Core Data Sheets and compliance with legal/regulatory requirements,

• Implements CMC changes in line with agreed company change control and global CMC plans

• Manages post-approval work not requiring a global project team including Post -approval Safety and Efficacy Studies, and other follow up measures

Qualifications and Experience:

• Graduate in Life Sciences in a relevant area, with post-graduate scientific and/or business qualifications

• Prior relevant experience in pharmaceutical Regulatory Affairs• Demonstrated planning and organisation skills.• Ability to prioritise and manage multiple projects.• Demonstrated analytical skills and ability to think strategically• Ability to work effectively and collaboratively across the organisation • Good interpersonal and negotiation skills and the ability to influence others without formal

authority• Excellent communication skills, both written and verbal• Willingness to travel as necessary

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, UKTel.: +44 207 193 9972 www.ctcresourcing.com info@ctcon.ch