Regulatory Affairs Consultant

Parexel currently has an excellent opportunity for Regulatory Affairs professionals with previous experience in the development of regulatory submissions to EMA.
This is a fantastic opportunity to work closely with our worldwide well-known pharmaceutical client.
This position is available on various seniority levels
- junior to mid-level:
Associate/ Senior Associate/ Consultant.The role of the Regulatory Generalist is to provide appropriate regulatory guidance to Project Teams for the development of regulatory submissions and responsible for the overall quality of submissions; manages, reviews, and organizes documents intended for submission to EMA to assure compliance with regulatorystandards.
This person would work with publishing as well as a Regulatory Lead to ensure on-time submissions to the EMA and possibly other regions.Skills:
Project management knowledge Client-focused approach to work Results orientation Teamwork and collaboration skills Consulting 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 languageQualificationsKnowledge 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