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Yuri, Regulatory Affairs Consultant, white male with brown hair and eyes, wearing a light blue button up shirt

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What does a day in the life of your role look like?

I am involved in the preparation of the regulatory dossiers to be submitted to the Competent Authorities for marketing or clinical trial authorization for innovative drug products, with a specific focus on CMC aspects. I work closely with the client and with many stakeholders, discussing and defining together strategies, content of documents and timing of preparation and submission to the authorities. Once the plan has been defined, a very important and demanding part of the work includes the preparation and review of the documents to be included in the dossier. In this phase there are multiple meetings and contacts with the various stakeholders, to retrieve all the information, discuss any critical issues, integrate and evaluate the suggestions and requests of the stakeholders, without losing sight of the timing and the general strategy. The activities do not end with the preparation of the dossier. Dossiers are living documents and you must always be ready to answer questions from the competent authorities and keep all information updated and aligned.

 

Why did you choose the Clinical Research industry?

For the opportunity to work in an international environment and follow the development of new and innovative products.

 

What part of your job are you passionate about and would like to share?

The opportunity to follow the development of a product, from the initial concept to the use in patients.

What skills are needed to be successful within your team?

Working 100% dedicated to a client, establishing a relationship of confidence and trust right away, while identifying the client's needs are key aspects. Attention to details, planning skills and knowledge of regulatory guidelines and the pharmaceutical world complete the whole.

How do you work "With Heart" and what does it mean to you?

Working 'With Heart' for me means working with passion and commitment, always giving 100% in all activities and trying to achieve the highest level of quality possible.

 

What have you experienced at Parexel but not anywhere else?

The high level of attention to the needs of the employees, as concerns both the personal life (flexibility, smart-working) the professional growth (trainings, mentorship, LMs always available to support and provide guidance).

 

How has Parexel supported your career growth?

Parexel is supporting my career in several different ways:
  • assign me a Technical Mentor and, recently, giving me the opportunity to be a Technical Mentor
  • including me in the C&PD project
  • allow participation to initiative, such as the "Article Writing Initiative"

 

How does Parexel/your Line Manager/your team support flexibility and work-life balance?

The level of attention to the need of the employees is very high. Remote working and opportunity to work from different locations is important for work-life balance.

 

How do you see our core value "Respect" in action within the company and your team?

It is a corporate value that is reflected in all activities. For example, in the Line Managers' approach to the needs of team members. All opinions and requests are welcomed, evaluated and discussed, respecting them and trying to enhance them, if and as possible.

How do you and your team take quality seriously?

 

All the activities are carried out following a quality-based approach and considering the client’s needs. For example, in my working activities, documents are prepared according to international guidelines and following client’s procedures; source documentation is checked to retrieve the information and the relevant SME and stakeholders are involved as needed. Further checks are performed to assure consistency of information within the dossier. In case of gaps or issues, solutions or mitigation actions are propose, shared and discussed with the team.

 

Are there any habits, behaviors, or beliefs you find to be helpful in your everyday personal and/or work activities?

Work hard, persevere through tough times, be humble and willing to learn from every opportunity, always lead to results and personal growth.

 

What do you enjoy outside of work?

Trekking and reading. I have a small garden; which I like take care of and grow vegetables.

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