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Regulatory Affairs CMC Senior Manager
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Client, Support
Projektbeschreibung
Regulatory Affairs CMC Senior Manager knowledge wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- Degree in Science, eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, or equivalent
- 4+ years' work experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management
- Proven practical knowledge of complex CMC regulatory issues and requirements as well as track record of successful work in interdisciplinary teams, leading activities simultaneously on multiple projects
- Ability to contribute line functions or project teams as well as to Matrix teams with the necessary strategic thinking
- Demonstrated ability for risk assessment, mitigation and awareness of business impact
- Languages: fluent English both written and spoken, well-spoken German desired
YOUR TASKS:
- Determining and leading global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximising the business benefit balanced with regulatory compliance
- Communicating CMC regulatory strategy and key issues throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and respective departments
- Implementing all global CMC submission activities for assigned projects, while applying the global strategy into submissions
- Authoring high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- Maintaining a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products
- Leading Health Authority interactions and negotiations, setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans
START: ASAP
DURATION: 12MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13075
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:
- Degree in Science, eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, or equivalent
- 4+ years' work experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management
- Proven practical knowledge of complex CMC regulatory issues and requirements as well as track record of successful work in interdisciplinary teams, leading activities simultaneously on multiple projects
- Ability to contribute line functions or project teams as well as to Matrix teams with the necessary strategic thinking
- Demonstrated ability for risk assessment, mitigation and awareness of business impact
- Languages: fluent English both written and spoken, well-spoken German desired
YOUR TASKS:
- Determining and leading global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximising the business benefit balanced with regulatory compliance
- Communicating CMC regulatory strategy and key issues throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and respective departments
- Implementing all global CMC submission activities for assigned projects, while applying the global strategy into submissions
- Authoring high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance
- Maintaining a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products
- Leading Health Authority interactions and negotiations, setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans
START: ASAP
DURATION: 12MM+
LOCATION: Basel, Switzerland
REF.NR.: BH13075
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
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Kategorie:
IT Entwicklung, Sonstiges