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Job Details

Regulatory Affairs Consultant (CMC)

Company: PAREXEL
Location: Bucharest, Bucure?ti,Romania
Reference: 49857BR
Closing Date: 23 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

PAREXEL values passion, global perspective and expertise and we are in the process of recruiting full time, permanent Regulatory Affairs Consultant (CMC focused) to join our PAREXEL Consulting team in Bucharest. PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. ...

Requirements:

PAREXEL values passion, global perspective and expertise and we are in the process of recruiting full time, permanent Regulatory Affairs Consultant (CMC focused) to join our PAREXEL Consulting team in Bucharest.
PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world.

Main responsiblities include:

• Variation/Lifecycle Maintenance compilation/submission's coordination for EU/RoW regions: e.g. Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.
• Change Control assessment experience or transferrable skills (application of relevant regulatory guidance to proposed change)
• Participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME.
• Strict adherence to timelines (both internal and HA deadlines).

Qualifications

Key requirements:

• Good understanding of performing the above regulatory tasks on a global level.
• Several years of Variation/ Lifecycle Maintenance experience.
• Relevant CMC Regulatory expertise.
• Good project Management skills.
• Proactive approach and excellent communication skills.
• Fluent English and Romanian.

Key requirements:

• Good understanding of performing the above regulatory tasks on a global level.
• Several years of Variation/ Lifecycle Maintenance experience.
• Relevant CMC Regulatory expertise.
• Good project Management skills.
• Proactive approach and excellent communication skills.
• Fluent English and Romanian.

Apply for this job: Regulatory Affairs Consultant (CMC)

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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