Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Senior Regulatory Affairs Manager Duration: 12 Months Rat: Up to £60 per hour Location: Buckinghamshire Remote Work: 1 day
Senior Regulatory Affairs Manager
Duration: 12 Months
Rat: Up to £60 per hour
Remote Work: 1 day
Regulatory Professionals have been tasked by a global pharmaceutical innovator to recruit a Senior Regulatory Manager for their site based in Buckinghamshire.
About the client:
A household name within the life sciences and healthcare business. This company is considered in the top five within the pharmaceutical industry. Operating in the Pharmaceutical, Consumer healthcare and medical devices markets, making it a leading firm in medical and consumer health innovation.
Their Buckinghamshire site is a brilliant facility that will allow you access to subsidised services and facilities such as café's restaurants, gyms and much more.
This is a brilliant opportunity for a Proficient Regulatory Manager with the right experience to step up into a senior position, or for those with exposure as a senior manager to work in an exciting new project with a renowned global firm.
About the role:
This is a 12 month contract for a Senior Regulatory Affairs Manager of which you'll be working with oncology products. You'll be responsible for providing input in development phases, post approval and life cycle management through advising the regulatory team on applicable regulatory requirements.
The remit of the Successful regulatory Professional will include, but not limited to:
*Input in clinical development, post-approval and life cycle management.
*Liaison with Regulatory Agencies and Local Operating Companies.
*Assist in development and improvement of processes related to regulatory submissions.
*Review clinical trial plans and protocols and ensure alignment with regulatory requirements.
*Provide regulatory support throughout registration process and life-cycle management.
*Advise team in required documents and submission strategies (in collaboration with LOCs as appropriate).
*Assist with timely availability of submission documents and ensure that all document components are in place on time.
*Draft and review some document content.
*Prepare, hold and lead cross functional team meetings as appropriate.
*Understand submission details and liaise with Submission Management.
*Review and approve submission plans.
*Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
*Serve as the Regulatory representative on specific multi-discipline teams.
The background required for the optimal Senior Regulatory Manager:
*Robust knowledge and proven experience with knowledge of regulatory requirements specifically with regards to submissions and of filing registration process.
*Understands dossier component requirements with a firm ability to critically review and compile dossier components and understands submission requirements for lifecycle submissions.
*Up-to-date knowledge of current and pending approvals in specific therapeutic areas
*Provide strategic input and technical guidance on regulatory requirements to development teams
*Firm understanding of life cycle of drug product from discovery through marketing and post-approval requirements.
*Minimum 5 + years regulatory experience
*A background within Oncology therapy is desirable, but other therapy areas will be considered.
*Proven experience in directly dealing with health authorities and or involvement in scientific advice meetings.
*Must be eligible to work in the UK.
Keywords: Regulatory Affairs Consultant, Regulatory Affairs Contractor, Regulatory Affairs Freelance, Manager, Senior manager, Oncology, Cardiovascular, Buckinghamshire, Berkshire, Hertfordshire, EU M4 Corridor, M40, Pre Approval, Post approval, EU, National, Contract, 6 months, Global Pharma, CMC, Infectious Diseases,
3rd floor 33 Blagrave Street Reading
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