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CMC Regulatory Affairs Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
TOP SKILLS SHOULD YOU POSSESS:
- Regulatory CMC
- Regulatory compliance
WHAT YOU'LL BE DOING:
- The scope of the work is to assist CMC Regulatory Affairs personnel by representing RA in project team meetings, assessing the content requirements for IND amendments or BLA supplements, assisting in the draft, review and/or editing of regulatory submissions
- Take responsibility for review and quality of published documents prior to submission to FDA, all with limited oversight.
WHAT YOU NEED TO BRING TO THE TABLE:
- Minimum of a Bachelor's Degree in a scientific discipline plus 5 or more years in Regulatory CMC or Regulatory Compliance with a focus on life cycle management for FDA-regulated biologics.
- A sound understanding of US regulation and regulatory expectations for biologics
- An understanding of biologics manufacturing and analytical methods.
- Background in a functional discipline related to biologics CMC a plus (cell banking, upstream or downstream operations, secondary manufacturing, validation, analytical testing)
- Ability to provide strategic regulatory input to project/submission teams on CMC-related topics; possess requisite knowledge and experience to identify topics that require escalation
- Expertise in the critical review of submissions for content and quality
- Understanding of cGMP regulations with a quality mindset. Experience assessing Change Control is a must.
- Aptitude to learn various IT systems as it relates to training, document creation, publishing activities, etc.
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Hannah Cihlar
Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.
J2W: CLINICAL
MONJOBJ2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
King Of Prussia, Russische Föderation
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung