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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

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

RM IT Professional Resources AG