Senior / Regulatory Affairs Consultant

4 giorni fa

Abruzzo, Italia Confidenziale A tempo pieno

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.This role can be either office based in Uxbridge or Dublin or you can be fully home based anywhere in the UK or Ireland respectively. The offices are open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. This role can also be office based or home based in the following countries:
Project Execution
- Typically works within a team environment but may work independently delivering services within their technical area of expertise
- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
- Demonstrates ability to prioritize work and definesteps needed to achieve specified project outcomesConsulting Activities and Relationship Management
- Follows and implements the organization’s consulting models and methodologies
- Provides technical and/or business consulting services within personal area of expertise - Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability
- Collaborates with colleagues and client to identify and resolve technical and process issuesBusiness Development
- Continue to build a network of industry colleagues through relationships formed Importante Azienda project engagements or through other industry experience
- Communicates potential new business leads to PC management and account managers
- May participate in project scoping calls and/or proposal preparation with the support of senior colleaguesParexel related responsibilities
- Meets established metrics as specified in scorecard on an annual basis - Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management. QualificationsEducation:

- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced degree preferred;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 languageExperience:

- Previous experience working in CRO, Pharma or a Regulatory agency in the capacity as Regulatory Affairs Consultant or Senior Regulatory Affairs Associate with a strong focus on CMC and particularly small molecules. - Thorough understanding of change management processes and regulatory requirements
- Good understanding of CMC lifecycle maintenance activities across EU and ROW markets

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