Regulatory Affairs Manager

Reference:   HQ24939
Salary sought:   £50,000
Basis:   Permanent
Availability:   Immediate
Location:   London / Southern Home Counties

Reliable, high-achieving and results oriented regulatory manager with over 6 years’ experience in regulatory affairs, drug safety and pharmacovigilance (R&D and commercial). QA experience gained as part of a cross-functional QA team. Methodical and calm, able to assess quickly and accurately the individual requirements of a project, ensuring that deadlines, budgets and objectives are efficiently achieved at all stages of the Life Cycle.

• Good negotiation and interpersonal skills as demonstrated by confident dealings with members of staff at all levels, Competent Authorities (CAs) and Consultant staff
• Successfully maintained the development of two Investigational Medicinal Products (IMPs) in one European (UK, Germany, France, Italy and Sweden) and International (UK and US) Stage I and Stage I/II Clinical Trials in a timely fashion
• Maintained two established oncology products through variations and renewals (CMC-life cycle management) by dealing extensively with MHRA and IMB
• Effectively liaised with Contract Research Organisations, Competent Authorities (CAs) and external service providers as required in order to complete timely submissions of regulatory dossiers in European countries
• Responsible for Regulatory, Safety, Medical Information and Pharmacovigilance budgets
• Managed and developed two members of staff within the Medical Information and Regulatory Department
• Dealt with a number of Medical Information Queries in relation to company products including stability, out of specifications and more general queries
• Ensured that advertising and promotional material was produced in line with regulations
• Supported from the regulatory perspective the out-licensing of company’s marketed drug in five European countries
• Assisted in GMP and GPvP inspections from CAs
• Excellent attention to detail – experienced in the review, comparison and updating of various reports and documents
• Ability to mentor new starters and guide them through the systems and procedures in use within a company, and also support them in the preparation of regulatory documents
• Proactive and positive attitude, especially when working under pressure to meet very tight deadlines
• Willingness to learn constantly and adapt to any role as required
• Successful management of regulatory and research projects, good planning skills shown by scheduling activities and data gathering well in advance and bringing projects to a successful conclusion

For further information please contact:
Sebastian Pennells
sebastian@bluepelican.com
01892 507 136