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Regulatory Affairs CMC Associate Manager

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support

Projektbeschreibung

Harvey Nash is looking for a Regulatory Affairs CMC Associate Manager for a 12 + month project in Switzerland.

The role is for a candidate to provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

You are responsible for; -Authoring 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
-Preparing CMC responses to health authority questions during development, registration and product life cycle
-Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines
-Identifying 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
-Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
-Actively participating as a member of the global Regulatory Affairs CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
-Establishing and maintaining sound working relationships with partners and customers

Requirements;

-Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent; desirable would be an Advanced Degree in Science
-Fluent English required (oral and written). Good skills in site (local) language desired (oral)
-0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
-Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines
-Knowledge/experience of regulations and product life cycle maintenance desirable
-Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
-Effective planning, organizational and interpersonal skills
-Reasonable approach to risk assessment
-Excellent written/spoken communication and negotiation skills
-Computer literacy

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12months +

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Harvey Nash IT Recruitment Switzerland