Taipei, Taiwan · On-site
The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start…
Skills: Regulatory Submissions, ICH-GCP Guidelines, Clinical Trial Start-Up, Stakeholder Management, Regulatory Compliance
Sydney, New South Wales, Australia · Hybrid
The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start…
Skills: Regulatory Submissions, ICH-GCP Guidelines, Clinical Trial Start-Up, Ethics Committee Applications, ICF Development
Bangalore, Karnataka, India · On-site
About the Role: The QA Auditor supports the functional head of QA in the provision of quality assurance activities within Novotech, primarily in audit activities. Responsibilities: Assist and lead (as applicable) with th…
Skills: Quality Assurance, Auditing, GCP, Clinical Research, Communication
Sofia, Sofia-City, Bulgaria · On-site
About the Role The Senior Regulatory Start-Up Associate (Senior RSA) is responsible for the planning, preparation, coordination, and submission of country- and site-level ethics and regulatory authority applications duri…
Skills: Regulatory Submissions, ICH-GCP Guidelines, EU Clinical Trial Regulation, Project Management, Stakeholder Management
Vienna, Austria · On-site
About the Role The Senior Regulatory Start-Up Associate (Senior RSA) is responsible for the planning, preparation, coordination, and submission of country- and site-level ethics and regulatory authority applications duri…
Skills: Regulatory Submissions, ICH-GCP Guidelines, EU Clinical Trial Regulation, Project Management, Stakeholder Management
Prague, Prague, Czechia · Hybrid
About the Role The Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical tri…
Skills: Regulatory Submissions, ICH-GCP Guidelines, Clinical Trial Start-Up, Project Management, Stakeholder Management
Sofia, Sofia-City, Bulgaria · On-site
Brief Position Description: The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements an…
Skills: Clinical Trial Management System (CTMS), Trial Master File (TMF) Management, ICH GCP Guidelines, Clinical Study Documentation, Quality Control Reviews
Bangalore, Karnataka, India · On-site
The Finance Assistant Role The Finance Assistant works as part of the Finance Reporting team (same as financial controlling team) primarily. The role is responsible for data entry, anything related to payroll administrat…
Skills: Data Entry, Payroll Administration, Financial Reporting, Month End Closing, Financial Statement Maintenance
Taipei, Taiwan · On-site
HR Analytics & Reporting Specialist Role The HR Analytics & Reporting Specialist is primarily responsible for collecting, organizing and analysing the data related to Human Resources. This includes attributes like employ…
Skills: HR Analytics, Data Analysis, Microsoft Excel, Data Presentation, Communication
City of London, England, United Kingdom · Hybrid
About the Opportunity The Director, Site Engagement & Feasibility provides strategic leadership and oversight of site engagement, site partnerships, and feasibility activities within Clinical Operations to support the gr…
Skills: Strategic Leadership, Site Engagement, Clinical Feasibility, Line Management, Stakeholder Management
Bucharest, Romania · On-site
About the Role The Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical tri…
Skills: Regulatory Submissions, Clinical Trial Start-Up, ICH-GCP Guidelines, Stakeholder Management, Planning And Alignment
Bangalore, Karnataka, India · On-site
About the Role: The CDP-II is responsible for the design, development, programming, validation, and maintenance of clinical trial databases throughout the study lifecycle. This includes clinical database build, Case Repo…
Skills: Medidata Rave, Veeva Vault EDC, Viedoc EDC, CDISC Standards, CDASH
Bangalore, Karnataka, India · On-site
About the Role: The Clinical Programmer (SDTM) is primarily responsible for SDTM programming based on Clinical Protocols, eCRF and Statistical Analysis Plans. The Clinical Programmer (SDTM) may also be responsible for da…
Skills: SAS Programming, SDTM Programming, Clinical Protocols, Statistical Analysis Plans, Define.xml
Sydney, New South Wales, Australia · Hybrid
The Regulatory Start-Up Associate II (RSA) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, an…
Skills: Regulatory Submissions, ICH-GCP Guidelines, Clinical Trial Start-Up, Ethics Committee Applications, Regulatory Authority Liaison
Bangalore, Karnataka, India · On-site
About the Role: We are looking for a high-impact, hands-on Manager – Finance GSC to act as the Second-in-Command (2IC) to the Head of Finance. This role is a full ownership position, responsible for running and scaling t…
Skills: Global Team Leadership, Accounts Payable, Accounts Receivable, Billing, Banking
Seoul, South Korea · Hybrid
The Proposal Associate prepares under guidance customer proposals, budgets and RFP responses for projects mainly of medium complexity, conducts proposal execution within established frameworks, ensuring submissions are t…
Skills: Proposal Management, Contract Drafting, RFP Response, Budgeting, Project Management
Bangalore, Karnataka, India · On-site
Description The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with stud…
Skills: Trial Master File Management, eTMF, ICH GCP Guidelines, Quality Control Review, Document Management
Charleston, South Carolina, United States · On-site
$110k–$145k/yr
Associate Regulatory Operations Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deli…
Skills: Regulatory Operations, Project Management, Regulatory Start Up, Risk Mitigation, Client Relationship Management
Seoul, South Korea · On-site
Responsibilities: Build and Grow Korea Domestic Sales Develop and execute a focused Korea commercial strategy targeting local biotech and mid-sized pharmaOriginate high-quality opportunities through deep client engagemen…
Skills: Business Development, Staff Management, Strategic Planning, Negotiation, Client Relationship Management
Melbourne, Victoria, Australia · Hybrid
About the role The Project Manager is primarily responsible for the planning and management of all contracted responsibilities for assigned projects. Act as primary contact between Novotech and client. Leads and oversees…
Skills: Project Management, Clinical Trial Conduct, Vendor Management, Budget Management, Risk Mitigation
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Responsible for planning, preparing, and reviewing ethics and regulatory authority submissions during the start-up phase of clinical trials. Ensures all submissions comply with ICH-GCP guidelines and local regulatory requirements to facilitate timely trial approvals.
Requires a degree in a clinical, pharmacy, or life sciences related field. Candidates should have 1-2 years of related experience in a CRO, pharmaceutical, or clinical/hospital environment.
The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and, where applicable, throughout maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals.
The RSA / RSL has an action-oriented mindset to proactively address challenges and advance start-up activities. The ability to balance stakeholders is essential, considering ethical, cultural, and organizational needs.
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
Biotech's Partner at Every Phase
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years. For more information or to speak to an expert team member visit www.Novotech-CRO.com
Offices: Level 52, 9 Raffles Place, Republic Plaza, Singapore 048619, Singapore , Singapore 049513, SG · Level 3, 235 Pyrmont Street, Pyrmont, Sydney, NSW 2009, AU · 6 F, The 21st Century Building No. 210, Century Avenue, Shanghai, Pudong New District 200120, CN · Unit 06-11, 16/F Grand Century Plaza Tower 2 193, Prince Edward Rd West Mongkok, Kowloon, Kowloon 999077, HK · Unit #104, Embassy Square, #148 Infantry Road, Bangalore, Bangalore 560001 , IN
Biotech's Partner at Every Phase
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years. For more information or to speak to an expert team member visit www.Novotech-CRO.com
Offices: Level 52, 9 Raffles Place, Republic Plaza, Singapore 048619, Singapore , Singapore 049513, SG · Level 3, 235 Pyrmont Street, Pyrmont, Sydney, NSW 2009, AU · 6 F, The 21st Century Building No. 210, Century Avenue, Shanghai, Pudong New District 200120, CN · Unit 06-11, 16/F Grand Century Plaza Tower 2 193, Prince Edward Rd West Mongkok, Kowloon, Kowloon 999077, HK · Unit #104, Embassy Square, #148 Infantry Road, Bangalore, Bangalore 560001 , IN
