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Consultant Regulatory Filing



Introductie

For Janssen Vaccines we are looking for an experienced Consultant Regulatory Filing. In this role you will be responsible for the molecular and bioassays and/ or analytical methods for products developed by Janssen Vaccines Leiden. In particular, you will be responsible for ensuring method validations meet the regulatory expectations and for translating Janssen Vaccines Leiden’s testing strategy ...

Het bedrijf / The company

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention we are searching for a Consultant Regulatory Filing.

Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Extra info

The Analytical Development department within Janssen Vaccines Leiden (one of the pharmaceutical companies of Johnson & Johnson) is responsible for developing methods that are required for analysis of vaccines for human use. Analysis includes testing for identity, quantity, potency, purity and contamination; in particular, extraneous agents safety.

De functie / The role

For Janssen Vaccines we are looking for an experienced Consultant Regulatory Filing.
In this role you will be responsible for the molecular and bioassays and/ or analytical methods for products developed by Janssen Vaccines Leiden. In particular, you will be responsible for ensuring method validations meet the regulatory expectations and for translating Janssen Vaccines Leiden’s testing strategy into company position papers and/or briefing books for health authority’s scientific advice.
Demonstrating flawless documentation, effective communication with varied levels of the organization, a strong sense of responsibility and a passion for quality are key competences for this position.

Het profiel / Your profile

The ideal candidate has a PhD degree with Regulatory Affairs specialization. You have minimal 5 years of experience with regulatory filing for biopharmaceuticals and knowledge of method development and validation. Proven excellent writing skills is a must.

Het aanbod / The offer

Project of at least one year, longer-term possibilities depending on budget approvals and proven added value.
Full time preferred, 32 hours discussable.


Reactie / Reaction

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form and click below at button "Solliciteer hier".

Tenslotte ..... / Finally ....

Reference:A1900112 Contract:Temporary contract with CLS Services Education:PhD. Employment terms:Project of at least one year, longer-term possibilities depending on budget approvals and proven added value.
Full time preferred, 32 hours discussable.
Publication date:16-9-2019Contactperson:Claudia Erwich-Faaij+31 (0)31 (0)88 22 77 555
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.



Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


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Gegevens

Werkgever:
Janssen Vaccines & Prevention
Vacaturesteller:
CLS Services
Standplaats:
Leiden

Geplaatst op FMF: 16 september 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: PhD
Werkervaring: 5-10 jaar