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Junior Regulatory Affairs Manager, Contract, Switzerland
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Support, Client
Projektbeschreibung
Start Date: ASAP
End Date: 16/12/2016
Location: Basel
Language: English
Job description:
Regulatory CMC Associate Manager
Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project life cycle.
- Prepare CMC responses to health authority questions during development, registration and product life cycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Establish and maintain sound working relationships with partners and customers.
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Key Performance Indicators (Indicate how performance for this job is measured)
- Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate documentation on matters within CMC control.
- No last minute source document issues identified that could have been prevented by early review of source documents.
- Ensure that CMC regulatory documentation follows guidelines and meets regulatory guidelines, as appropriate (eg measured by approval of CMC documentation, and no non-approvals due to CMC issues under our control).
- Positive customer feedback
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.
Key Words: Regulatory affairs, CMC regulatory documentation, NCE guidelines, planning, strategies, regulatory compliace, support, English, Switzerland
Kind regards,
Serena Edith Alpi
Michael Bailey Associates
Job code: 111723
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
End Date: 16/12/2016
Location: Basel
Language: English
Job description:
Regulatory CMC Associate Manager
Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project life cycle.
- Prepare CMC responses to health authority questions during development, registration and product life cycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Establish and maintain sound working relationships with partners and customers.
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Key Performance Indicators (Indicate how performance for this job is measured)
- Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate documentation on matters within CMC control.
- No last minute source document issues identified that could have been prevented by early review of source documents.
- Ensure that CMC regulatory documentation follows guidelines and meets regulatory guidelines, as appropriate (eg measured by approval of CMC documentation, and no non-approvals due to CMC issues under our control).
- Positive customer feedback
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.
Key Words: Regulatory affairs, CMC regulatory documentation, NCE guidelines, planning, strategies, regulatory compliace, support, English, Switzerland
Kind regards,
Serena Edith Alpi
Michael Bailey Associates
Job code: 111723
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges