Associate Director/Sr Manager Regulatory Affairs Manager, EU Markets
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 Stewart Hulse directly on 01932 234681 for a confidential discussion regarding your job search.
Are you a Regulatory Affairs Manager with significant experience of defining regulatory strategy?
Are you seeking a role where your efforts will be rewarded with and excellent package and great career prospects?
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 include the management of both permanent and temporary staff.
Our client is seeking candidates who can define regulatory strategies and subsequently implement these strategies^across Europe. The ideal candidate will have a solid track record in managing international regulatory affairs across all aspects of a development project including Clinical Trials, Scientific Advisory aspects, PIPs and MAAs. Orphan Drug and device experience is desirable but not essential.
Here the European Regulatory Development team is responsible for all the regulatory activities leading up to positive opinion for new marketing authorisation's (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&D study design, regulatory intelligence, to the most^advantageous filing pathway.
Operationally the group co-ordinates the compilation of all clinical trial application documents and oversees CROs who submit these locally, therefore candidate having previously worked with and managed external vendors would be highly advantageous. The group also prepare and submit: EU Scientific Advice; Pediatric Investigation Plans (PIPs); orphan drug applications; IMPDs in addition to marketing authorisation applications (MAAs) across a number of therapy areas^(Neuroscience, Ophthalmology, Medical Dermatology,Urology and Aesthetic Medicine).
This is a high performing team that prides itself on sharing best industry practice and developing creative regulatory strategies for new products.
Essential^Skills & Qualification
Established EU or regional regulatory experience across all aspects of a development project including Clinical Trials, Scientific Advice, PIPs and MAAs.
Extensive experience of the registration of new products or indications via CP, DCP and MRIP
Strong, proven communication skills in order to foster relationships with global teams based in US headquarters
A positive problem solving approach and good commercial acumen
Experience working with the Centralised Procedure is desirable
Orphan Drug and device experience is desirable but not essential.
This is not a line management position
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,