Regulatory and Start Up Specialist

2 weeks ago

Bucharest, Bucureşti, Romania IQVIA Full time €104,000 - €130,878 per year

Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based. Romanian language proficiency required.

Essential Functions

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines.
  • Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

Qualifications
Bachelor's Degree Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.

  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge, if applicable.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company's Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Associate Regulatory and Start Up Manager

    2 weeks ago

    Bucharest, Bucureşti, Romania IQVIA Full time €60,000 - €80,000 per year

    Job OverviewDirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.Essential FunctionsOversee the execution of Site Activation (including pre-award/bid defense activities) and/or...

  • Junior Quality and Regulatory Specialist

    2 weeks ago

    Bucharest, Bucureşti, Romania SOFMEDICA Life-saving Innovation Full time 25,000 - 40,000 per year

    SOFMEDICA is a leading regional multinational company that distributes innovative medical equipment harnessing the power of precision to improve healthcare outcomes. We are deeply committed to bridging the gap between cutting-edge medical technology and patients in Central and Southeastern Europe.We are looking for aJunior Quality and Regulatory Specialistto...

  • Regulatory Affairs Maintenance Specialist APAC

    2 weeks ago

    Bucharest, Bucureşti, Romania Lotus Support Services Full time €60,000 - €80,000 per year

    Regulatory Affairs Senior Specialist APAC(Maintenance)Job Requirements:Education:University degree in Pharmacy, Chemistry, Biology, Biochemistry, Medicine, Life SciencesWork Experience: At least 3 years' experience in Global Regulatory AffairsCandidate Requirements:·      At least 3 years Regulatory Affairs (international...

  • Regulatory Compliance Officer

    2 weeks ago

    Bucharest, Bucureşti, Romania TBI BANK Full time 40,000 - 60,000 per year

    Who we are:Do you want to join a well-established bank with a start-up culture? No, we're not jokingWe, at tbi, have been one the most profitable banks for years and we are growing at a fast pace. We're a bank with a long history of success that operates as a start-up and we're always on the lookout for new opportunities to grow our business. How do we do...

  • Regulatory Compliance Officer

    2 weeks ago

    Bucharest, Bucureşti, Romania TBI BANK RO Full time €40,000 - €60,000 per year

    Who we are: Do you want to join a well-established bank with a start-up culture? No, we're not joking We, at tbi, have been one the most profitable banks for years and we are growing at a fast pace. We're a bank with a long history of success that operates as a start-up and we're always on the lookout for new opportunities to grow our business. How do we...

  • tart up Coordinator PMT for Offshore Development Project in Romania

    2 weeks ago

    Bucharest, Bucureşti, Romania Procer Worldwide Technical Services Full time €90,000 - €120,000 per year

    CSU Start up Coordinator PMT for Offshore Development Project in RomaniaProcer recruits for its Client, Major Operator in Oil&Gas, a Start up Coordinator for its Subsea gas development project on Black Sea Romania.Role DefinitionThe role willbe responsible for the readiness, assurance, permitting and authorisations in relation to the startup of the Neptun...

  • Regulatory Reporting Analyst

    2 weeks ago

    Bucharest, Bucureşti, Romania Societe Generale Global Solution Centre Romania Full time €104,000 - €130,878 per year

    Reference 25000DT6ResponsibilitiesResponsible of the implementation of processes within Regulatory team and the production of reports on a solo or on a consolidated basis for Societe Generale Group.Specifically, you will be required to:Responsible of the production of regulatory reports on a standalone / consolidated basis for Societe Generale Group such as...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Bucharest, Bucureşti, Romania Lotus Pharmaceutical Co., Ltd Full time €40,000 - €60,000 per year

    About the Company:Founded in 1966, Lotus (1795: TT) is international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in...

  • Regulatory PM

    2 days ago

    Bucharest, Bucureşti, Romania Societe Generale Global Solution Centre Romania Full time €30,000 - €60,000 per year

    Societe Generale Global Solution Centre(SG GSC) acts as a business solution center for Societe Generale, one of the largest European financial groups. We provide high-quality professional services for more than 35 countries in various fields of activity – Finance & Accounting, HR, IT and Corporate Operations. Our mission is to be a partner of choice,...

  • Senior Regulatory Affairs Associate

    5 hours ago

    Bucharest, Bucureşti, Romania Parexel Full time 40,000 - 60,000 per year

    We are seeking a highly organized and strategic Senior Regulatory Affairs Associate specializing in Artworks to join our team. In this pivotal role, you will work with various clients, develop and execute artwork strategies for our global product portfolio, ensuring comprehensive oversight throughout the product lifecycle.The role can be home or office based...