Senior Associate, EU Regulatory Affairs

Job summary
•European Regulatory Development team
•Office based Marlow
•Permanent with client
•Global Pharma

Job Background

The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Senior Associate, EU Regulatory Affairs
to work for our client, a global Pharma company. This role offers the chance to broaden your experience across the EU, working on development projects, new product registrations, PIPs, variations and some innovative and exciting new indications. This is a permanent headcount position.

Job Primary Functions
The European Regulatory Development team is responsible for all the regulatory activities leading up to positive opinion for new marketing authorisations (global projects) and new clinical indications within the European Union.

The team is responsible for strategic input to Global Project Teams via Global Regulatory Affairs and includes regional advice ranging from the regulatory aspects of R Paediatric Investigation Plans (PIPs); orphan drug applications; IMPDs in addition to marketing authorisation applications (MAAs) across a number of therapy areas, including Ophthalmology.

•Ensures planned drug development activities comply with EU guidelines and in cases where they do not provides a critical analysis of the risks and issues
•Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional /commercial objectives.
•Supports the drug development strategy, defining options for Scientific advice, creating briefing packages and co-ordinating and leading EU SA meetings
•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.
•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.
•With supervision, ensures effective handover from development team.

You will need the following experience;

•Graduate in Life Sciences in a relevant area, with post-graduate scientific and/or business qualifications
•Prior relevant experience in pharmaceutical Regulatory Affairs

•To successfully represent the needs of the European region the person we are seeking will need good communication skills in order to foster relationships with global teams based in EU affiliates and a proactive can do approach.
•They will be able to put together responses to functional area questions and be able to use software systems to track submissions.
•They have good working knowledge across all aspects of a development project including Clinical Trials, Scientific Advice, PIPs and MAAs. Ideally they will have experience of CTA applications and liaising with third party suppliers.

Our ideal candidate is confident and competent, and has built their reputation on their ability to deliver, work flexibly and efficiently, and in overcoming problems with solutions that work.

A full job description is available

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Keywords:

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