Regulatory Affairs Manager
Pharmaceutical company based in Buckinghamshire
Our client is a leading pharmaceutical company, located in Buckinghamshire. Working across multiple therapy areas, they research and develop both ethical and consumer health products and devices in a range of therapy areas including dermatology, ophthalmology, neurology and other speciality markets.
Located within easy reach of the M40, and mainline BR, our client boasts modern spacious offices with ample free car parking. Generally speaking, roles with this client are fully office based and there is limited scope for home working. Office facilities include onsite restaurant, and a relaxed 'coffee shop' area.
CSL are privileged to have a longstanding relationship with this client and have made many placements both for permanent and contract openings so can really vouch for them when we say that candidate feedback is extremely positive and this is a great place to work.
Our client offers a generous package, usually made up of a basic salary, performance related bonus, healthcare and generous annual leave allowance. We do regularly handle openings with this client, so if this sounds like the sort of place you would like to work, please contact Sue Spice on 01932 228928 for a confidential discussion regarding your job search.
Are you a Regulatory Affairs Manager with significant experience of the UK and Ireland?
Are you seeking a role where^your efforts will be rewarded with and excellent package and great career prospects?
Are you looking for an autonomous and high profile role?
Then read on.
Much work is led by this company, rather than outsourced, and you will have an excellent opportunity to build on experience to date and this role will provide support in the implementation of the regulatory strategy for Europe specifically within the UK and Ireland for the registration and post licensing of EU Medicinal products. In this position you will have the opportunity to sit on the UK Management team as well as interact with Global CMC and Global Labelling. This is a great opportunity to step into a fully responsible and autonomous role with the opportunity for wide and broad exposure within the UK organisation and the wider EU and Global teams.
Our client is seeking candidates who can:
Review and approve product related material ensuring regulatory compliance including Patient Information Leaflet user testing
Build relationships with key stakeholders including those within Regulatory agencies
Ensure that local Regulatory activities are aligned with Global plans
Manage marketed product labelling to ensure alignment with core data sheets and compliance^with legal/ regulatory requirements
Implements CMC changes in line with Global CMC plans
Manages post approval work not requiring Global team
Assist and provide support with any inspections
Plans and implements regulatory activities in support of^lifecycle management (renewals and variations)
Essential Skills & Qualification
Established EU or UK & Ireland regulatory experience across all aspects of a development project
Extensive experience of the registration of new products or indications via CP, DCP and MRIP
Must have had direct UK & Ireland submissions experience in renewals and variations
Good direct interaction with UK and Ireland Health Authorises
Experience of artwork implementation
Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within UK/Ireland and/or Europe
A positive problem solving approach and good commercial acumen
Experience working with the Centralised Procedure is desirable
Software Competence: MS Office, MS Project, Zinc, DOCUMENTUM
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: No
Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time only 37.5 hours
Location: M/M40 near Maidenhead, Berkshire, UK
Benefits: Good basic plus Company Pension, Performance related bonus of 10% at target, with upside and downside potential, company car, or cash for car option, Life Insurance, Private Healthcare, Dental Care,
DOCUMENTUM, Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency, PIPs, CRO Clinical Trial Authorisation, CTAs, MAAs, global, centralised procedure, orphan drug, cosmetic, aesthetic, devices. Maidenhead, Berkshire, international.
Assigned Consultant: Sue Spice at CSL Recruitment on 01932 228928
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you