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Job Details

Regulatory Submission Manager

Company: i-Pharm Consulting
Location: Berkshire
Reference: NIBE10052
Closing Date: 09 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Regulatory Submissions Manager My client, a leading Regulatory Affairs CRO, is looking for an experienced candidate to join their development team as a Regulatory Submissions Manager. My client works with over 400 global pharmaceutical and biotechnology customers and they need a strong candidate to manage CTA submissions. Candidates must be eligible to work in the UK. ...

Requirements:

Regulatory Submissions Manager

My client, a leading Regulatory Affairs CRO, is looking for an experienced candidate to join their development team as a Regulatory Submissions Manager. My client works with over 400 global pharmaceutical and biotechnology customers and they need a strong candidate to manage CTA submissions. Candidates must be eligible to work in the UK.

Job Title: Regulator Manager
Location: Berkshire
Benefits: Very good annual salary + benefits

Job Responsibilities
• Manage Regulatory Submissions prior to clinical trials
• Responsible for ensuring that submission documentation is maintained in a timely manner
• for timely preparation/coordination of regulatory submissions
• Ensure that documents are prepared to the required standards by maintaining awareness of current regulatory standards related to drug submissions and clinical research team.


Ideal Candidate
1. Minimum of a science degree with further education ideal (MSc, PhD)
2. Strong understanding of the regulatory environment including guidelines
3. In depth knowledge of CTA applications
4. Knowledge of ICH/GCP and clinical trial directive
5. Leadership experience would be good
6. Ability to work under pressure and achieve timely submission and regulatory approvals
7. 3+ years’ experience within Regulatory CTA
8. Strong communication style and the ability to liaise directly with clients
9. Ability to project manage

TO APPLY
If you would like to discuss this vacancy further, please call Regulatory Affairs Recruitment Consultant on +44 (0)20 3189 0463, or email nbehan@i-pharmconsulting.com. If this role is not suitable, Niall is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

KEY WORDS

Pharmaceutical, Biotech, Biotechnology, Biochemistry, CRO, Pharma, Pharmaceutical, Clinical, Clinical Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Senior Manager, Senior Regulatory Affairs Manager, Regulatory Affairs Management, Reg Affairs, Reg Affairs Manager, Regulatory Affairs Coordinator, Regulatory Affairs Consultant, Principal Consultant, Principal Regulatory Consultant, Regulatory Affairs Associate, Regulatory Affairs Officer, Regulatory Affairs Expert, Regulatory Affairs Specialist, Regulatory Affairs Executive Associate, Submissions, GRA, RA, Regulatory Affairs Submissions Associate, Regulatory Affairs Submissions Coordinator, RA Submissions Coordinator, Senior Regulatory Affairs Associate, Regulatory Submissions, Regulatory, Regulatory Affairs Associate, Regulatory Affairs Associate II, Regulatory Line Management, Oncology, cardiovascular, vaccines, general medicines, CNS, Respiratory, London, England, UK, Greater London, Central London, East London, West London, North London, South London, Cambridge

Apply for this job: Regulatory Submission Manager

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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