Regulatory Manager
- Location:
- South East jobs
- Salary:
- £45000 - £50000 per annum + Benefits
- Company:
- SRG Clinical
- Job type:
- Permanent jobs
- Date posted:
- 04/11/2009 14:48
- Job id:
- 45844325
- Contact:
- Luke Chapman
- Ref:
- Totaljobs/17227
SRG Clinical are working with a company to recruit for a Regulatory Affairs Manager who can provide leadership, and ensure all aspects of the Regulatory and Safety functions run smoothly in a reliable, timely and accurate fashion and in accordance with legislative framework.
You will be responsible for:
Developing the regulatory and safety function in Europe and ROW in preparation for future filing and commercialisation of the company's products.
Maintaining and evolving the processes and procedures to enable the company to meet its pharmacovigilance obligations for investigational as well as marketed products.
Monitoring and advise on the labelling of relevant products.
Ensuring that all designated projects are completed in a timely fashion in accordance with the company's SOPs and applicable guidelines.
Assisting in the establishment and co-ordination of national and international meetings of multidisciplinary experts, staff, and other third parties to facilitate the approach, format, and progress of projects.
Providing strategic and writing support to the Medical Writing function when required.
Ensuring the completion of critical materials according to relevant standards of the Company and ICH. Documentation may include:
·study proposals
·investigator brochures
·protocols
·clinical trial applications
·clinical study reports
·publications, abstracts, posters, and slide presentations
·authority briefing materials
·elements of MAAs in existing and future CTD formats
·labelling texts (IMP labels, Summaries of Product Characteristics, Patient Information Leaflets)
·pharmacovigilance reports including PSURs or similar
·To ensure that appropriate processes are in place in order to meet the pharmacovigilance requirements set out in Volume 9a of the Rules Governing Medicinal Products in the European Union
Interested applicants will hold a Life Sciences degree (Or equivalent) and have proven industrial experience of working within regulatory affairs within the Pharmaceutical industry. You will also be able to demonstrate excellent written and oral communication skill with the ability to communicate effectively at all levels, have excellent presentation and interpersonal skills and can demonstrate flexibility.
For a confidential discussion, please contact Priya Mukherjee on 0207 562 1791 or email an updated CV to priya@srgclinical.com
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
