vor etwa 1 Monat | P-13-7443

Regulatory Manager (m/f/d)

Ort
Basel
Anstellung
Temporär, Vollzeit
Bereich
Pharma
Bewerben

Description

In this role you will provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. You will be responsible for: - Author 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 lifecycle - 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

Motivation

Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!

Company description

Global Pharma Company.

Special

If you are interested then kindly send your resume to: a.tschanz@universaljob.ch

Experience

- 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 - 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

Education

Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent

Languages

English : Very good

Start of work

Asap

Age

Open

Vacancy number

P-13-7443

Bewerben

Anja Tschanz

Universal-Job AG
Kasinostrasse 32
5000 Aarau

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