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Regulatory Affairs Consultant (CMC)

Employer
Parexel
Location
Bucharest, Romania
Salary
Competitive
Start date
12 Nov 2019
Closing date
12 Dec 2019

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details


We are currently looking for an experienced Consultant who will have the following responsibilities:
  • CMC Submission of Simple (Type I) and complex variations (Type II) to EU markets in the CP, MRP and NP procedures. Experience working with APAC and LATAM submissions would be of benefit.
  • Change Control assessment experience (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
  • 'Proactive' and 'efficient working method
  • Strict adherence to timelines (both internal and HA deadlines)


Qualifications

Key Skills Required:
  • Good understanding of performing the above regulatory tasks on a global level.
  • Minimum of 3 years of Variation/ Life-cycle Maintenance experience.
  • Relevant CMC Regulatory expertise.
  • Good project Management skills.
  • Proactive approach and excellent communication skills.
  • Fluent English and Romanian.

Knowledge and Experience:
  • Several years of experience in an industry-related environment.

Education:
  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.


Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Find Us
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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