Regulatory Start Up Manager

2 days ago


บางกอกนอย กรงเทพมหานคร, Thailand Novotech Asia Full time

The Regulatory Start-Up Manager (RSM) is primarily responsible to to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client's expectations.

Minimum Qualifications & Experience:

- Graduate in a clinical, pharmacy or life sciences related field.
- At least 5 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations
- Through knowledge of applicable regulations
- Able to manage in a matrix environment
- Confident decision-making and problem-solving
- Competent working in virtual teams across time zones
- Strong presentation, documentation, and interpersonal skills
- High proficiency in English

**Responsibilities**:

- Define a Regulatory Start-Up (RSU) strategy and prepare a RSU management plan
- Oversee the execution of regulatory start-up for assigned projects in accordance with agreed RSU strategy.
- Ensure collaboration with local regulatory start-up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
- Distribute start-up related documents to local regulatory start-up teams
- Oversee customization of core start-up documents to local requirements
- Ensure preparation and distribution of core contract and budget templates to applicable team members.
- Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines
- Oversee site activation package compilation and approvals
- Proactively identify any risks to start-up and escalate to Project Manager. Develop RSU mitigation plans.
- Provide timely update of regulatory start-up progress to Project Manager
- Present at external and internal meetings including but not limited to: project internal and external meetings, kick-off meetings.
- Serve as a client's contact for regulatory start-up related items
- Support business development by providing relevant information on regulatory start-up and attending Bid Defences to present Novotech's regional capabilities
- Ensure accurate completion and maintenance of internal systems including CTMS, relevant databases, and tracking tools,
- Deliver presentation/training to clients and internal/external stakeholders regarding regulatory start-up activities
- Facilitate cooperation between cross-functional teams
- Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence
- Identify areas of inefficiency in regulatory start-up process and make recommendation for improvements.
- Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings).
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.



  • บางกอกใหญ่, กรุงเทพมหานคร, Thailand Novotech Asia Full time

    Core Responsibilities: - Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. - Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices...

  • Start-up Manager

    7 months ago


    กรุงเทพมหานคร, Thailand Lotus Bakeries Full time

    Thailand- BangkokAre you an experienced and innovative professional seeking an exciting opportunity to shape the success of a new greenfield factory? We are currently looking for a Strategic Start-Up Manager to join our dynamic team and lead the team in establishing our cutting-edge facility. This pivotal role requires an individual with exceptional...

  • Start-up Manager

    9 months ago


    กรุงเทพมหานคร, Thailand Lotus Bakeries Full time

    Thailand Bangkok Are you an experienced and innovative professional seeking an exciting opportunity to shape the success of a new greenfield factory? We are currently looking for a Strategic Start-Up Manager to join our dynamic team and lead the team in establishing our cutting-edge facility. This pivotal role requires an individual with exceptional...


  • กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **Study Start-Up Manager** **Job Summary**: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site...


  • กรุงเทพมหานคร, Thailand AstraZeneca Full time

    **Job summary**: The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations. The SSU Manager will prepare, review, track and manage site regulatory documentation at...


  • กรุงเทพมหานคร, Thailand Icon plc Full time

    Study Start Up Associate - Thailand, Bangkok - Office Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior...


  • กรุงเทพมหานคร, Thailand MSD Full time

    **Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for...


  • กรุงเทพมหานคร, Thailand ICON Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...


  • กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery,...


  • กรุงเทพมหานคร, Thailand PRTR Full time

    Our client is an Agency for Real Estate (Startup) with HQ in Canada. **Responsibilities** - Centrally managing documents (forms, bills, contracts, etc.). - Managing the orderliness of the office. - Supporting internal department and external coordinating on documents and contracts. - Contacting supplier for office management. - Controlling and managing...


  • กรุงเทพมหานคร, Thailand Rxilient Medical (Thailand) Co., Ltd Full time

    Directly report to local Business Manager and be responsible on local regulatory submissions, developing regulatory strategies, and ensuring compliance with applicable laws and regulations. You will collaborate with various internal departments and external agencies to achieve regulatory objectives and support business goals. Additionally, you will stay up...


  • กรุงเทพมหานคร, Thailand HydroNeo (Thailand) Co., Ltd. Full time

    To expand our activities, we are looking for a Project Manager for our startup. We are looking for a hands-on and pragmatic person who can drive own projects and take over responsibilities for a changing array of business-related tasks and projects. HydroNeo is an international start-up supporting the Thai aquaculture industry with a focus on shrimp...


  • กรุงเทพมหานคร, Thailand DKSH (Thailand) Limited Full time

    About DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality...


  • กรุงเทพมหานคร, Thailand Organon Full time

    **The Position** The RAaPV Senior Specialist is responsible for all aspects of regulatory submissions in the assigned markets. Critical to this role is to combine knowledge of scientific, and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on...


  • กรุงเทพมหานคร, Thailand Elanco Full time

    Education : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...


  • กรุงเทพมหานคร, Thailand Vinarco Full time

    Job Description: **Location**: Pathumwan, Bangkok **Type of Hiring**: Permanent **Responsibilities**: - Independently manage routine regulatory activities for the assigned product portfolio. - Oversee the registration of new products and line extensions according to the planned schedule to ensure timely product launches. - Handle the renewal of product...


  • กรุงเทพมหานคร, Thailand Suntory Oceania Full time

    **Requisition ID**:8464 Job Responsibilities- Oversee regulatory compliance throughout new product development, from conception to commercialization, ensuring all necessary approvals are secured. - Identify and mitigate regulatory risks early in the development phase to ensure product feasibility. - Manage product registration and amendments with the Thai...


  • กรุงเทพมหานคร, Thailand TMS Talent Full time

    Regulatory Affairs Manager - Medical Devices IVD **Responsibilities**: Develop and execute effective regulatory strategies and plans for medical devices IVD, focusing on compliance with Thai FDA regulations. Collaborate closely with cross-functional teams to ensure regulatory compliance throughout the product lifecycle, encompassing development,...


  • กรุงเทพมหานคร, Thailand Citi Full time

    Whether you’re at the start of your career or looking to discover your next adventure, your story begins here. At **Citi**, you’ll have the opportunity to expand your skills and make a difference at one of the world’s most global banks. We’re fully committed to supporting your growth and development from the start with extensive on-the-job training...


  • กรุงเทพมหานคร, Thailand ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...