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Regcmc Associate Manager
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Support, Client
Projektbeschreibung
RegCMC Associate Manager wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- Advanced degree in pharmacy, biochemistry, biotechnology or equivalent
- Working knowledge of biotechnology, analytics, pharmaceutical technology or drug development processes
- Knowledge of regulations and guidelines for NCEs and product life cycle maintenance
- Work experience in international project teams along with excellent communication and negotiation skills
- Languages: fluent English both written and spoken
YOUR TASKS:
- Authoring high-quality CMC documentation with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, and e-publishing throughout project life cycle as an actively participant of a global team
- Keeping knowledge up to date with regard to regulatory guidelines and new technical trends
- Identifying required documentation for global submissions and negotiate the delivery of approved technical source documents
- Supporting the general department such as DRAGON support, annual and product renewal writing, source documentation and other database entry activities
START: ASAP
DURATION: 15MM+
LOCATION: Basel, Switzerland
REF.NR.: BH11653
Does this sound like an interesting and challenging opportunity to you?
Then take the next step by sending us your CV as a Word document and a 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:
- Advanced degree in pharmacy, biochemistry, biotechnology or equivalent
- Working knowledge of biotechnology, analytics, pharmaceutical technology or drug development processes
- Knowledge of regulations and guidelines for NCEs and product life cycle maintenance
- Work experience in international project teams along with excellent communication and negotiation skills
- Languages: fluent English both written and spoken
YOUR TASKS:
- Authoring high-quality CMC documentation with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, and e-publishing throughout project life cycle as an actively participant of a global team
- Keeping knowledge up to date with regard to regulatory guidelines and new technical trends
- Identifying required documentation for global submissions and negotiate the delivery of approved technical source documents
- Supporting the general department such as DRAGON support, annual and product renewal writing, source documentation and other database entry activities
START: ASAP
DURATION: 15MM+
LOCATION: Basel, Switzerland
REF.NR.: BH11653
Does this sound like an interesting and challenging opportunity to you?
Then take the next step by sending us your CV as a Word document and a 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