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Regulatory Affairs CMC Associate Manager

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support, Client

Projektbeschreibung

Regulatory Affairs CMC Associate Manager

You are an expert in regulatory affairs specialist ideally with knowledge of CMC regulation? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!

Our client, an international pharmaceutical company, is looking for you!

Under supervision, you provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

These activities include:

- Author high-quality CMC documentation for Health Authority (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
- Prepare CMC responses to health authority questions during development, registration and product life cycle
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Identify 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
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
- Establish and maintain sound working relationships with partners and customers
- Assume activities in support of the general department such as DRAGON (Drug Reg Affairs Global Regulatory Compliance System) support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions)

Your Profile:

- Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
- Chemistry/Pharmacy background with a little bit of knowledge of pharma industry and/or CMC but should mainly show interest for Lean/Six Sigma approach.
- Regulatory experience 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, guidelines for NCEs 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
- Fluent English required (oral and written)
- Good skills in German

We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.

If you are the person we're looking for please submit your application. We're looking forward to getting to know you.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    11 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland