Our client is the fastest growing global ophthalmic company and holds leadership positions in 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.

Regulatory Affairs Manager

Reference Number: 893201-W Type of placement: Permanent Location: Marlow, Buckinghamshire - UK Purpose The Regulatory Affairs Manager plans and prepares regulatory submission documents for regulatory filings for all medical devices in Europe, Africa and Middle East (EAME). Utilizing an understanding of medical device regulations, provides global project and regulatory teams with timely input and guidance. Supports management with implementation of departmental strategies and policies Main Responsibilities

Product Development and Registrations

With some supervision, provides clear, constructive regulatory advice and guidance to global project and regulatory teams.

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

Prepares regulatory documents for product approval in EAME.

Supports the maintenance of Design Dossiers and Technical Files ensuring contents are current and accurate.

Performs peer review of regulatory documents, as required.

Establishes strong and effective relationships with global regulatory teams thereby ensuring RA activities are in line with global and regional business priorities.

Business Support

Provides effective technical/scientific input to the Brand Teams, supporting the development and review of compliant promotional materials.

Reviews labelling and packaging components to ensure accuracy and compliance with governmental regulations.

Working with regional commercial teams and senior management, agrees priorities and clearly conveys project timelines, risks and opportunities.

Process and Compliance

Supports the development and implementation of processes to leverage the global infrastructure and maximise efficiency.

Maintains a state of audit/inspection-readiness.

Provides input into critical metrics and management reports. Organisational Effectiveness

Takes personal responsibility for the notification of Regulatory activities and related database entry/data accuracy for allocated projects.

Represents the Regulatory Affairs team at internal and external meetings in a professional manner.

Maintains a performance and improvement culture and shares best practice where possible.

Provides appropriate input into budget and forecast development. Qualifications and Experience

A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs; the length of which is dependent on the level of qualifications achieved

Sound Medical Device experience, including a successful track record in the registration and maintenance of products within the Europe, Africa and Middle East region.

Sound knowledge of relevant Quality Standards.

Excellent organisational/ planning and negotiation skills.

Excellent English communication skills, both written and verbal.

Good interpersonal skills and the ability to influence others without formal authority.

Ability to work effectively and collaboratively across the global organisation and cross-functionally.

Ability to coordinate and synchronize multiple projects and be flexible in changing daily workload priorities.

Our offer:

Competitive Basic Salary

Car Allowance

Bonus

Pension Plan

Life Assurance of 4 x salary.

Private Health

Long term disability insurance

Childcare Vouchers

25 days holiday per calendar year 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

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