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Regulatory Affairs Specialist

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Company :
Katalyst Healthcares & Life Sciences

Location :
Summit, New Jersey

Expiry Date :
Sun, 08 Nov 2020 23:59:59 GMT

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Description :
Job Details

ContractEstimated: $56,000 – $75,000 a year4 hours ago

Qualifications

– Microsoft Excel
– Laboratory experience
– MRP
– Chemistry, manufacturing & controls
– Microsoft Powerpoint
– Bachelor’s degree
– Doctoral degree
– Master’s degree

Full Job Description

Responsibilities:

– Marketed product support for global maintenance (US, EU, and ROW) activities
– Assessment of change controls from Industrial Affairs and dossier requirements
– Ensure dossier publishing with Reg Ops with any necessary coordination with GRA Leads
– Creation of any response documents and coordination with all partners for completion
– Appropriate database management (VEEVA RT, etc.)
– Renewal activities according to current SOPs and Global Planning for all markets
– Variation Tracking with Affiliates
– Other support activities including administrative documents for all submission types
– eCTD Application Forms (MRP, CP, etc.)
– Other activities such as below may be assigned based on the level and ability of the incumbent.
– Regional/Pharmaceutical Operations/Industrial Affairs sponsored non-R & D life-cycle management projects
– Territory extensions / new registrations
– Support of initiatives within Reg CMC

Job Skills:

– Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.
– Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.
– Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
– Fluency (oral and written) in English language is strongly recommended.
– Potential to be able to mentor and train other contractors is desirable but not essential.
– Be proficient in the use of databases and tools (Regulatory databases, Excel, PowerPoint, etc.).

Requirement:

– Minimum of a Bachelors degree; advanced degree (Masters, PhD) in a science/health field (eg: Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable
– An understanding of Regulatory CMC and eCTD content Modules 1-3 through technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) or direct Regulatory CMC experience is required.

Job Type: Contract

Schedule:

– 8 hour shift

Work Location:

– One location

Work Remotely:

– No

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