Regulatory & Start-up Specialist

3 days ago

Singapore IQVIA Full time

**Responsibilities**:

- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /CRDs, other roles.
- Executes and oversees clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
- Required to in/directly influence investigators, external partners and country operations to adheres to budget targets and agreed payment timelines.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions.

**Requirements**:

- 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
- Bachelor's Degree in Life Science or equivalent Health Care related experience
- Excellent verbal and written influencing and training/mentoring skills, in local language and English
- Strong coordination and organizational skills
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up

  • Regulatory and Start Up Specialist

    6 days ago

    Singapore Precision for Medicine Full time

    Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition...

  • Procurement & Admin Specialist (Inventory & Negotiations)

    5 days ago

    Singapore Start Up Development Full time

    A growing logistics firm in Singapore is looking for a responsible individual to manage inventory and vendor relationships. The role involves reviewing orders, negotiating prices, and ensuring timely deliveries. Candidates should hold a diploma or degree, and being bilingual in English and Mandarin is essential. This position requires a proactive approach to...

  • Site Start-up Associate Ii

    5 days ago

    Singapore Premier Research Full time

    Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices. We're looking for a talented and energetic...

  • Start-up Financing Specialist

    1 week ago

    Singapore Funding Societies | Modalku Group Full time

    **Funding Societies | Modalku** is the largest SME digital financing platform in Southeast Asia, expanding into a leading SME neobank. We are licensed and registered in Singapore, Indonesia, Thailand, Malaysia, and operating in Vietnam, and backed by Sequoia India, Softbank Vision Fund and SMBC bank amongst many others. Funding Societies | Modalku provides...

  • Senior / Regional Regulatory Affairs Specialist [Pharma / Up to 6K]

    7 hours ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    An excellent opportunity has come up with an international Pharmaceutical MNC and they are currently looking for a Senior / Regional Regulatory Affairs Specialist to join the team in Singapore. The successful incumbent will drive the implementation of global guidelines and work alongside local RA functions to ensure product approvals. You will also exhibit...

  • Salesforce Marketing Cloud Specialist

    1 day ago

    Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $10,000 - $17,000 Per Month **Date Posted** 18 hours ago Additional Details **Job ID** 2236 **Job Views** 3 Roles & Responsibilities **Role Summary** As an SFMC Technical Specialist, you will be responsible for understanding and defining the data flows into and outside...

  • Regulatory Affairs Specialist, Chemicals

    2 weeks ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Full Time**Salary** - $3,500 - $5,500 Per Month**Date Posted** - 1 hour agoAdditional Details **Job ID** - 103882**Job Views** - 1Roles & Responsibilities **Job Title: Regulatory Affairs Specialist, Chemicals** **Reports to: Sr Manager, Business Process Excellence** **Location: Marsiling,...

  • Senior / Regional Regulatory Affairs Specialist [pharma / Up to 6k]

    1 week ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    An excellent opportunity has come up with an international Pharmaceutical MNC and they are currently looking for a **Senior / Regional Regulatory Affairs Specialist**to join the team in Singapore. The successful incumbent will drive the implementation of global guidelines and work alongside local RA functions to ensure product approvals. You will also...

  • Regulatory Affair Specialist Asia Pacific

    2 weeks ago

    Singapore DSM-Firmenich AG Full time

    Job ID **75321** **Job title -**Regulatory Affair Specialist Asia Pacific **Location -**Singapore **Job model -**Hybrid As the Regulatory Affair Specialist of Perfumery & Beauty (P&B) responsible of Asia Pacific region (APAC), your primary responsibility will be to ensure regulatory and safety compliance of all P&B products offered in APAC. This...

  • Regulatory Affairs Specialist

    5 days ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...