Location: United States
Closing Date: 27 May 17
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below
TalentSource Life Sciences is currently searching for a Regulatory Manager to work with one of our partner pharmaceutical companies in the United States. This is freelance position for 0.8 FTE and will be home based. The successful candidate will be working on studies dedicated to one client. TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions.
TalentSource Life Sciences is currently searching for a Regulatory Manager to work with one of our partner pharmaceutical companies in the United States.
This is freelance position for 0.8 FTE and will be home based. The successful candidate will be working on studies dedicated to one client.
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.
- Plans, organises, writes, compiles and submits documentation for a variety of EU and other regulatory pharmaceutical and medical device applications and submissions as well as any required, or needed updates to those documents, to the appropriate competent authorities.
- Reviews documentation provided by clients, prepares gap analysis and writes or supervises the writing of documentation to fill those gaps for pharmaceutical and medical device applications and submissions.
- Maintains accurate and complete regulatory history files, electronic and/or paper, for all regulatory submissions and communications for all assigned regulatory projects.
- Organises and participates in meetings with the Competent Authorities (I.e. FDA, HMRA) and Notified Bodies as needed.
- Serves as regulatory contact/authorised agent to MHRA for assigned regulatory projects.
- Provides regulatory guidance on cross-departmental project teams
- Serves as an unblended team member on any assigned project involving blinded activities.
- Reviews and analyses medical device and drug product labels for compliance with US, EU and ROW regulations.
- Performs a quality check on assigned submission documents.
- Develops procedures and templates required for the provision of regulatory services.
- Maintains current knowledge of global regulations, analyse industry trends; makes recommendations to ensure continued compliance; contributes to the preparation of the quarterly Regulatory Newsletter.
- Contributes to the update and maintenance of regulatory information databases as requested.
- Cooperates, when applicable and if request, with the Client Project Development Division personnel, in participating in business lead generation.
- Participates in external training, reads professional publications, maintains personal networks to keep knowledge concerning regulatory affairs up-to-date.
- Develops, with the input of the Training & Qualification Management Unit, regulatory related training materials providing operational support
- Performs Regulatory Affairs training in cooperation with the Department Head.
- Supervises the daily activities of the Regulatory Affairs Associates.
- Strong prior experience in a similar role within Regulatory Affairs within the pharmaceutical or Medical Device arena with responsibility for EU, USA or Canadian regulatory activities. Previous experience working in a CRO would be advantageous.
- Previous experience working on Haematology studies is preferred.
- Knowledge of medical device and pharmaceutical regulations required for the EU
- Experience with eCTD publishing and e-submission platforms
- Knowledge of ISO 9001 and ISO EN 14155
- Knowledge of GXPs (i.e. GCP, GLP, GMP)
- Good understanding of clinical research; good understanding of drug and/or device development; good understanding of statistical methods would be advantageous.
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook) and Adobe Acrobat Pro
- Educated to degree level in scientific, medical, or similar discipline
- Excellent spoken and written English
Why choose TalentSource Life Sciences/Cromsource?
Cromsource is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge
Cromsource comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with Cromsource and you will be working on studies for just one client.
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Key words: Regulatory Manager, Regulatory Affairs Manager, Reg Affairs, Regulatory Affairs, RA Manager, RA, RAM, CRO
Regulatory Manager, Freelance
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
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