Iulia Danciu, PhD

Experience

• 

  Faculty of Biology, University of Bucharest

  Jun 2006 - Jul 2006

  Undergraduate Research Assistant
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  Faculty of Biology,University of Bucharest

  May 2007 - Jul 2007

  Research Internship
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  Faculty of Biology, University of Bucharest

  Jun 2008 - Oct 2008

  Research Assistant
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  Genetic Lab

  Oct 2008 - Sept 2010

  Biochemist

  Perform genetic tests for viral and bacterial infection detection/quantification and for pre/post-natal screening for genetic diseases: - genetic screening for Duchenne Muscular Dystrophy (DMD);- viral hepatitis (B, C or D) and other viruses (CMV, Parvovirus B19, HIV, HPV) detection and quantification;- bacteria (Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, Chlamydia trachomatis) detection;

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  Roche

  Jan 2011 - Jan 2011

  Sales Representative

  - Responsible for establishing and maintaining relationships with customers;- Take orders, ask for client's opinion, provide information about new products and services, keep complete progress reports;- Keep abreast of new developments in the field in order to provide competitive information to customers;

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  Teva Pharmaceuticals

  Nov 2016 - Jul 2017

  Pharmacovigilance Associate II

  - Prepare global pharmacovigilance agreements;- Ensure compliance with pharmacovigilance regulations applicable in each territory;-Coordinate PhV interactions between different departments (RA, Periodic Reports and Risk Management Plan Center, Legal Dep., BD Dep., etc);- Support global PhV department and help/support affiliate PhV departments;- Attend conferences and scientific meetings;- Stay updated with emerging law, regulations and guidelines and assure process compliance with local guidelines and standards for safety reporting; Show less

• 

  Alvogen

  Jul 2017 - Jul 2020

  Regulatory Affairs Submission Officer (CEE and APAC countries)

  - Compile, review and publish submission dossiers in the electronic system (docuBridge) in eCTD, ACTD and National formats for local teams from various countries in APAC and CEE regions, following the local requirements and submission format (electronic/paper format);- Work closely with other members of the regulatory affairs department to support the preparation of electronic submissions;- Review the submission documents and detect any inconsistencies; report findings for correction;- Review sequences and provide technical support for colleagues and local teams;- Perform follow-up on the assigned tasks;- Monitor the status of the applications;- Maintain an archive of regulatory submissions and approvals received from regulatory local agencies, in accordance with the company's internal procedures;- Maintain regulatory databases and trackers updated;- Review and update the templates created in the electronic system as per the latest local regulatory affairs requirements;- Report electronic publishing software issues to the Help Desk of the software provider;- Stay up to date with the regulatory guidelines and legislation; Show less

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  Parexel

  Jul 2020 - now

  - Acting as Data Quality Lead, overseeing and supervising the team responsible for updating and QC-ing regulatory submissions data and information on client's working platforms and within internal tracking tools.- Prioritising work requirements and managing workload for myself and my team members.- Generating and updating project monthly reports related to the workload, personnel changes, and completion of onboarding activities by new joiners.- Coordinating remediation of non-compliant records based on internal and client findings.- Improving/developing quality control processes for submissions' data generated within the project.- Managing and responding to urgent operational needs, as required from the client or from Parexel.- Participating in client and internal meetings focused on improving the overall project performance/ data quality.- Involved in maintaining the partnership finances.- Overseeing that processes are properly being transferred from the client to the Data Quality Control Specialist and first-time quality deliverables are provided back to the client. Show less - Gathering regulatory intelligence for initial marketing authorization applications and lifecycle maintenance submissions (variations, renewals) in global regulatory frameworks for a major pharma company;- Contributing to process development/improvement.- Preparing regulatory documentation for marketing authorization transfers and life cycle maintenance activities in EU, UK and LATAM markets, to ensure complete and high-quality deliverables needed for submissions to regulatory agencies. - Interacting with the publishing team and reviewing the final output necessary for marketing authorization transfers submissions and lifecycle maintenance activities. - Maintaining client's regulatory compliance databases, systems, and processes.- Attending relevant meetings to advocate realistic deliverable timelines, understand project strategy, assess associated impact and present status of global submission delivery activities.- Assisting in client meetings and proactively liaising with clients on regulatory issues.- Maintaining awareness of current regulation and guidelines related to drug products submissions. Show less

  • Regulatory Affairs Consultant

    Dec 2021 - now

  • Senior Regulatory Affairs Associate

    Jul 2020 - Dec 2021