Job Description

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 Milan or you can be fully home based anywhere in Italy. The office is open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world.

As the Senior / Regulatory Associate (level depending on experience) you will have a knowledge of the organization's basic consulting models and methodologies aswell as basic knowledge of what services the group provides. You must be technically competent andcontinually developing the skills as defined in the key accountabilities section . You will also under the general direction of a Project Lead and/or Technical SME, take responsibility forensuring that client work is performed, and delivered on time, meeting the quality expectations of the group andthe client.

Key Accountabilities:

Project Execution
- Works effectively within a team environment
-With the guidance of the project Technical SME, demonstrates the ability toprioritize work to achieve specified project outcomes
-Liaise with colleagues to plan, organize, compile, progress, track and submit regulatory submissions (CTA, Substantial Amendments, etc.) on a timely basis to the Italian Medicines Agency (AIFA).
- Effectively communicate to the Regulatory Lead and relevant project team members the status and action plans concerning submissions and advise the project team about appropriate regulatory strategies
- Review and make recommendations on all relevant regulatory documentation e.g. labels, country specific requirements.
- Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management.

Consulting Activities and Relationship Management
- Follows and implements the organization's consulting models andmethodologies under the guidance of the project lead and/or Technical SME
- Delivers a limited range of consulting services within personal area ofexpertise under the guidance of the Project Lead and/or Technical SME
- Completes assigned activities within project scope and objectives under thedirection of the Project Lead and/or Technical SME

Business Development
- Begin networking within the industry (i.e. maintain contacts and relationshipswith clients once engagements are complete)
- Communicates potential new business lead to PC management and accountmanagers

Parexel related responsibilities
- Meets established metrics as specified in scorecard on an annual basis
-Completes basic job-related responsibilities, including timesheets, expensereports, maintenance of CVs, training compliance, project deliverablearchiving, participation in internal initiatives/projects
- Defines self-development activities with the support of management in orderto keep current within the industry.Qualifications

Education:
- 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 language

Knowledge and Experience:
- Basic previous experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus
- Previous CRO or Pharma experience acting in the capacity of Senior Regulatory Affairs Associate or Regulatory Affairs Associate would be desirable.
- Client-focused approach to work (Quality)
- Regulatory Italian CTA submission experience is desirable

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.