Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Regulatory CMC Associate Manager
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Vba, Client, Support
Projektbeschreibung
Reg CMC Associate Manager wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- Degree or advanced degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
- Several years working experience in regulatory and/or drug/biopharmaceuticals
- Good knowledge of data mining/analysis, reporting and programming
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology as well as the drug development process
- Knowledge of regulations, guidelines for New Chemical Entities and product life cycle maintenance is desirable
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
- Proficiency in Excel and knowledge of VBA, experience with one or several other programming languages is a strong asset
- Excellent written/spoken communication and negotiation skills, fluent English both written and spoken, German skills are an asset
YOUR TASKS:
Providing timely preparation of high quality CMC regulatory documentation and contributing to global regulatory submissions and strategies under supervision.
- Authoring high-quality CMC documentation, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents
- Identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
- Keeping up to date with regulatory guidelines and requirements in all global regions
- Contributing to the regulatory strategy and identifying the critical issues and lessons learned
START: ASAP
DURATION: 12MM++
LOCATION: Basel, Switzerland
REF.NR.: BH10295
Does this sound interesting? Does this sound like a challenging opportunity to you? Then take the next step and send us your CV as a Word Document and a daytime contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- Degree or advanced degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
- Several years working experience in regulatory and/or drug/biopharmaceuticals
- Good knowledge of data mining/analysis, reporting and programming
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology as well as the drug development process
- Knowledge of regulations, guidelines for New Chemical Entities and product life cycle maintenance is desirable
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
- Proficiency in Excel and knowledge of VBA, experience with one or several other programming languages is a strong asset
- Excellent written/spoken communication and negotiation skills, fluent English both written and spoken, German skills are an asset
YOUR TASKS:
Providing timely preparation of high quality CMC regulatory documentation and contributing to global regulatory submissions and strategies under supervision.
- Authoring high-quality CMC documentation, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- Preparing CMC responses to health authority questions during development, registration and product life cycle
- Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents
- Identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
- Keeping up to date with regulatory guidelines and requirements in all global regions
- Contributing to the regulatory strategy and identifying the critical issues and lessons learned
START: ASAP
DURATION: 12MM++
LOCATION: Basel, Switzerland
REF.NR.: BH10295
Does this sound interesting? Does this sound like a challenging opportunity to you? Then take the next step and send us your CV as a Word Document and a daytime contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges