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Senior Regulatory Affairs Associate (CMC biologics)

Employer
Parexel
Location
Uxbridge, United Kingdom
Salary
Competitive
Start date
12 Feb 2019
Closing date
14 Mar 2019

View more

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

Job Details


PAREXEL Consulting is looking for Senior Regulatory Associate with CMC biologics expertise.

A Senior Associate must be technically competent and continually developing the skills as defined in the responsibilities section of this document. A Senior Associate, under the general direction of a Project Lead and Technical SMEs, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management.
Qualifications
  • Good understanding of CMC biologics. Previous experience in writing respective documents (CTD module 3) advantageous.
  • Few years of experience in an industry-related environment.
  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
  • Client-focused approach to work.
  • Results orientation.
  • Teamwork and collaboration skills.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
  • Critical thinking and problem-solving skills.
  • Proficiency in local language and extensive working knowledge of the English language.
  • Good understanding of CMC biologics. Previous experience in writing respective documents (CTD module 3) advantageous.
  • Few years of experience in an industry-related environment.
  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline
  • Client-focused approach to work.
  • Results orientation.
  • Teamwork and collaboration skills.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
  • Critical thinking and problem-solving skills.
  • Proficiency in local language and extensive working knowledge of the English language.

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.

 

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

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