Senior Regulatory Consultant - Full Time - One Year Project Details


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Project Description:

Open position for Senior Regulatory Consultant (> 7 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:

● Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of CLIENT and regulatory requirements and guidelines, procedures and best practices, including compliance.
● For assigned project(s), as requested and monitored by the CLIENT project lead(s)/team(s), act as an accountable agent on behalf of CLIENT to the U.S. Food and Drug Administration (FDA) and via CLIENT affiliates as applicable to work with ex-US Health Authorities and support RAFT or equivalent members for related activities.
● Provide experienced stakeholder management as directed by the CLIENT project lead(s)/team(s), interfacing directly with internal stakeholders of various levels.
● 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:

SENIOR CONSULTANT RELEVANT EXPERIENCE:
❖ Clinical regulatory role in industry.
❖ > 7 years experience.
❖ Relates to Regulatory Affairs Director level in Program Management
❖ Fully competent in teamwork (cross functional)/collaboration, achieving results, regulatory knowledge, operational excellence.
❖ Fully competent in strategic agility, communication (stakeholder management), leadership, pharma drug development, organizational and business knowledge.
❖ Level of direct therapeutic area experience is role dependent.
❖ Experience in regulatory affairs (US, EU, ROW); experienced in submission requirements and HA interactions.
❖ Knowledge of GxP, ICH, and other regulatory guidelines; experience in providing regulatory assessments and guidance including considering precedence and relevant HA guidance through many project-level activities.
❖ Knowledge and deep experience of the drug development process from IND/CTA opening through final product approval, and how other functions contribute to a regulatory submission (IND/CTA/IMPD, NDA/BLA/ANDA/MAA, etc.).
❖ Strong regulatory program management, leadership, teamwork, and communication skills.

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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