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CMC Regulatory Manager - 100%


  • A hirdetés 812 napja lejárt

Our customer, an international pharmaceutical company with headquarters in Basel, is looking for a

CMC Regulatory Manager

for a temporary assignment.



The CMC Regulatory Manager in Small Molecules Marketed will be responsible to support global CMC regulatory teams to help write CMC sections of post-approval marketing applications, support renewal and answers to deficiency letters. You will support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents.


Responsibilities
- Author high-quality CMC documentation for HA submission
- Assuring technical congruency and regulatory compliance
- Prepare CMC responses to health authority questions during development, registration and product lifecycle
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- 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 Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
- Requirements

Qualifications:

- University degree in chemistry, pharmacy, life sciences or equivalent
- 2 years or more experience in pharmaceutical CMC regulatory affairs, formulation development, quality, or analytical development is required; experience post-approval submission is advantageous
- Must be detail oriented with excellent interpersonal skills
- Good English-language speaking and written skills are required


Assignment start: As soon as possible
Contract duration: > 6 months
Service level: 100%
Location: Basel
If you are interested in this position and bring the required experiences and skills, please apply online or send your full application (CV, copies of your diploma and reference letters) to Mr Kevin Jenny ().
Region: Basel
Vertragsart: Befristet
Kategorie: Naturwissenschaft/Forschung
Veröffentlicht am: 22.08.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1307-750
Abteilung: As a candidate within your own professional scientific or clinical career path today-to stay ahead of the latest innovation, technology, or regulations driving your science industry specialisation-you need an expert that can, and will, truly advocate your talent.
Kelly Scientific Resources has evolved as a world-leading career advisor, trusted since 1995 by thousands like you across the scientific workforce for expert guidance in every aspect of their careers.Link megjelenítése" width="0" height="0" />
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