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Job Details

Regulatory Affairs Consultant

Company: PAREXEL
Location: Dublin, Leinster,Ireland
Reference: 47453BR
Closing Date: 15 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

Clinical Consultant:A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides.A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. ...

Requirements:

Clinical Consultant:

A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides.
A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.Qualifications

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
  • Several years of experience in an industry-related environment
  • Experience with module 2.5 and 2.7 documents
  • Basic understanding of clinical and labelling lifecycle maintenance activities across EU and ROW markets
  • Change Control assessment experience
  • Would benefit from PSUR update experience, management of CCDS updates and submission experience of simple and complex variations to EU markets,
  • Capable of 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)
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Client-focused approach to work (Quality)
  • Results orientation
  • Teamwork and collaboration skills
  • Critical thinking and problem-solving skills
  • Proficiency in local language and extensive working knowledge of the English language
  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
  • Several years of experience in an industry-related environment
  • Experience with module 2.5 and 2.7 documents
  • Basic understanding of clinical and labelling lifecycle maintenance activities across EU and ROW markets
  • Change Control assessment experience
  • Would benefit from PSUR update experience, management of CCDS updates and submission experience of simple and complex variations to EU markets,
  • Capable of 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)
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Client-focused approach to work (Quality)
  • Results orientation
  • Teamwork and collaboration skills
  • Critical thinking and problem-solving skills
  • Proficiency in local language and extensive working knowledge of the English language

Apply for this job: Regulatory Affairs Consultant

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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