RegulatoryAffairs Manager Preclinical specialist
Oasmia Pharmaceutical AB / Apotekarjobb / Uppsala
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We are looking for a Regulatory Affairs Manager experienced in CTD Module 2 and 4 for human pharmaceuticals and Part 3 Safety / Part 4 Preclinical for veterinary pharmaceuticals.
You will actively participate in the development of preclinical and regulatory strategies for specific oncology products,both for human and veterinary use.
The goal is global registration.
Responsibilities include:
• Coordination, collection, development, review and approval of pre-clinical documentation for Human and Veterinarian equivalent regulatory submissions.
• Questions/Answers in discussions with authorities, partners and consultants in regards to preclinical issues and scientific advice or regulatory pre submission meetings.
• Planning, oversight, and reporting for submission of Target Animal Safety Studies.
• Approval of Pre-clinical information in product information, i.e. Investigational Brochure, SPC, Package Insert, Client information, Patient information etc.
• Participate as regulatory pre-clinical representative in project groups such as for clinical trials, R&D product development etc.
• Development and maintain SOPs (standard operating procedures) in regards to pre-clinical studies, documentation, information and submissions.
• Maintain awareness of and expertise in ICH, VICH, FDA, EMEA etc. guidelines and regulations in regards to pre-clinical.
• Maintain plans with critical milestones for regular status updating of pre-clinical documentation/studies and submissions.
Education and experience
You have a degree, preferably PhD or equivalent, within Life Sciences and are specialized within the preclinical field with good knowledge in toxicology and pharmacology.
You have several years of work experience within the field, preferably at the pharmaceutical industry or regulatory authority.
It is an advantage if you have experience with electronic applications (E-CTD) and product development and report writing within oncology is valued.
Personal attributes
You pay attention to details, are well structured and deliver results on time.
You should be able to work independently and plan your work.
For more information please contact
Head of Regulatory Affairs John Cosby 018 50 54 40
Send your application before April 15th, 2011 to:
jobb@oasmia.comPubliceringsdatum2011-04-05Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2011-04-15
Ansökan kan skickas till e-postadress:
jobb@oasmia.comFöretagOASMIA PHARMACEUTICAL AB
AdressOASMIA PHARMACEUTICAL AB
VALLONGATAN 1
75228 UPPSALA
KontorsadressVALLONGATAN 1
UPPSALA
KontaktuppgifterTelefonnummer: 018-505440
Jobbnummer 895797
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