Junior Regulatory Consultant - Full time -One year Project Details


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Project Description:

Junior Regulatory Consultant (> 2 years relevant experience)

Full time work. Initial contract will be for one year.

This is remote work. There is not need for working on the client site.

Required competencies are:

● Supports Regulatory Program Management Program Leads and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities.
● Establishes effective working relationships internally and externally with regulatory authorities.
● Documents meetings, teleconferences and other interactions/communications with regulatory authorities.
● Additional regulatory- and project-related support activities/Services as requested by the CLIENT project lead(s)/team(s).
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Suggested experience requirements are defined below:

JUNIOR CONSULTANT RELEVANT EXPERIENCE:
❖ Clinical regulatory role in industry.
❖ > 2 years experience.
❖ Relates to Regulatory Affairs Program Manager level.
❖ Fully competent in teamwork/collaboration, achieving results, regulatory knowledge, operational excellence and organized.
❖ Level of direct therapeutic area experience is role dependent.
❖ Knowledge of GxP, ICH, and other regulatory guidelines.
❖ Knowledge of the drug development process and how other functions contribute.
❖ Strong regulatory program management, leadership, teamwork, and communication skills.
❖ Strong verbal and writing skills; proficient in MS Office apps.
❖ EXAMPLES OF WORK: Support IND/NDA/BLA maintenance, support filings (INDs, BLAs, NDAs), support FDA meetings, support post marketing activities, representing regulatory at study team meetings, and answer regulatory questions.

Hours of work:

8 hour(s) per Day

Project Duration:

6 Months - 2 Years

Skills Required:

Location:

United Kingdom » European Union

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