Regulatory Affairs Specialist, Iqvia Biotech

3 meses atrás

Lisboa, Portugal Novasyte Tempo inteiro

Regulatory Affairs Specialist, IQVIA Biotech

Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.

Essential Functions:

- Acts as a Regulatory Team Member on regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
- Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labelling/ Publishing as applicable;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
- Understands the Scope of Work, deliverables for any given project;
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
- May prepare and deliver trainings, as appropriate;
- Performs other tasks or assignments, as delegated by Regulatory management;
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;
Qualifications:

- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- At least 2 years regulatory experience within a CRO/ Pharmaceutical company
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate
- Good, solid interpersonal communication (oral and written) and organisation skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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