Regulatory Start Up Manager

2 days ago


New Zealand 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.



  • New Zealand Technical Recruitment Solutions Full time

    Leading global organisation - Key regulatory position with growth opportunities - Auckland location **The Organisation**: Our client is a global leader in their field, employing hundreds of thousands of people across most of the countries in the world. They are involved in many of the products we take for granted in our daily lives. Their NZ head office is...


  • New Zealand Consult Recruitment Full time

    **A little bit about the company** Our client is a long-standing and growing commercial property investment and management company with offices located across New Zealand. With thousands of local and overseas investors, they have a significant investment portfolio and an established reputation. **Some more information about the role** This is a sole...


  • New Zealand Zagro Full time

    Orion AgriScience Limited, a subsidiary of Zagro Group of Companies, is a leading manufacturer and distributor of Crop Protection and Animal Health products in New Zealand. We seek an energetic, driven, competent and dedicated professional to join the Team. **Regulatory Affairs Manager (Agri-Chemical)** **Base Location: New Zealand**: **Summary** Orion...


  • New Zealand Alpha Laboratories NZ Ltd Full time

    **Job Title: Regulatory Affairs Officer** **Location: Auckland** This role will be a permanent, full-time position and will be guaranteed 40 hours of work per week. You will be paid an hourly rate of NZD 29.66 NZD 30.00 depending on your experience and skill level. Paid fortnightly, 4 weeks annual leave, Statutory holidays, Sick and bereavement leave....


  • New Zealand New Zealand Government Full time

    We are the Financial Markets Authority - Te Mana Tātai Hokohoko. As New Zealand's financial markets conduct regulator, we're looking to create something special. In fact, we believe our approach to regulating financial markets will be a world first. You'll be helping New Zealanders to have confidence that our financial sector provides a strong foundation...


  • New Zealand BSI Full time

    Great that you're thinking about a career with BSI! **Job Description**: What duties you'll perform: - As a RS Client Manager, you'll be responsible for frequently travelling and having overnight stays across the New Zealand. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up...


  • New Plymouth, New Zealand This Is An It Support Group Full time

    We are looking for a skilled Senior Regulatory Advisor to manage regulatory processes, ensure compliance, and drive strategic regulatory initiatives. In this key role, you will work closely with senior leaders and regulators, influence decision-making, and ensure the business meets all regulatory requirements.If you have extensive experience in a regulatory...


  • New Plymouth, New Zealand Paragon Recruitment Ltd Full time

    We are looking for a skilled Senior Regulatory Advisor to manage regulatory processes, ensure compliance, and drive strategic regulatory initiatives. In this key role, you will work closely with senior leaders and regulators, influence decision-making, and ensure the business meets all regulatory requirements.If you have extensive experience in a regulatory...


  • New Plymouth, New Zealand Paragon Recruitment Ltd Full time

    We are looking for a skilled Senior Regulatory Advisor to manage regulatory processes, ensure compliance, and drive strategic regulatory initiatives. In this key role, you will work closely with senior leaders and regulators, influence decision-making, and ensure the business meets all regulatory requirements. If you have extensive experience in a...


  • New Zealand Quinn Staff Recruitment Full time

    **Long-term assignment**: - ** Start tomorrow!**: - ** East Tamaki Location** **Do you have an impressive background within customer service and administration? Seeking variety in your next role? Contact Rachel at Quinn on **(09) 309 8821** or click APPLY now!** Looking for a role starting tomorrow? In between roles? Looking for flexible hours? This...


  • New Plymouth, New Zealand Lgjobs Full time

    Ko wai matou - Who are weTe Kaunihera-a-rohe o Ngamotu - New Plymouth District Council is a local government organisation located in the heart of New Plymouth. Our vision is to be the Sustainable Lifestyle Capital, and our district boasts a spectacular natural beauty from Taranaki Maunga to the moana. In 2021, we were awarded the most liveable city (for a...


  • New Zealand Johnson & Johnson Family of Companies Full time

    ***: The Regulatory Management Centre (RMC) Liaison is a regional member of the RMC and is responsible for the regulatory management of lifecycle submissions and activities in Asia Pacific (AP) for their assigned therapeutic area/s and product portfolios. The RMC Liaison supports the RMC Submission Professionals based in the AP LOCs, who are responsible for...

  • Up-cycle Your Essays!

    11 hours ago


    New Zealand Emprego NZ Full time

    **Up-cycle your essays! Students or Recent Graduates in Finance, Property, Business or Real Estate** Are you a student or recent graduate with a hot take on the world of property? Do you have key insights into the trades and services industry? Do you have a bunch of essays you wrote for uni gathering cobwebs in an unused Google Doc? **Well, then Property...


  • New Zealand Quinn Staff Recruitment Full time

    **ACCOUNTS ADMINISTRATOR - ASAP Start** - ** 6-month assignment**: - ** Flexible hours available**: - ** East Tamaki Location** Looking for a role starting tomorrow? In between roles? Looking for flexible hours? This crucial position will provide a key support function within a busy team based in East Tamaki. Our client is looking for an experienced...


  • New Zealand Te Whatu Ora - Health New Zealand Full time

    **Contribute to the future of health in this Group Manager, Young People role**: - **Flexible working supported to balance your workplace and lifestyle** Join Te Whatu Ora at a key time of change where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health system. This is mahi that will...

  • Accounts Administrator

    7 months ago


    New Zealand Alpha Personnel Recruitment Ltd Full time

    **The company and opportunity**: My client is based in East Tamaki, and they are 100% Kiwi-owned and operated. They provide all the machinery, accessories, services, and software you need to process timber, panel, aluminum, and associated materials. The role will be varied and, being a small team, they would expect the successful person to becomefamiliar...


  • New Zealand Alpha Personnel Recruitment Ltd Full time

    Based at Airport Oaks Temporary Assignment 3 months Biosecurity & Environmental Industry New Zealands premier, independent provider of Biosecurity and environmental training, auditing and inspection services are looking for someone to manage their team of trainers and training activities for the next 3 months. They are committed to helping exporters and...

  • Compliance Officer

    8 months ago


    New Zealand Technical Recruitment Solutions Full time

    Work for an internationally backed dairy manufacturer! - Based in North Waikato / South Auckland - Join the team during an exciting growth period for the business **The Company**:Our client is a well-established nutritional dairy manufacturer. They are internationally backed and run from their state-of-the-art manufacturing plant in the North Waikato. This...


  • New Zealand Coned Up Traffic Management Solutions Full time

    **About the role** We are looking for TMP designers to assist with our growing workload throughout New Zealand. Ideally you will be experienced in Traffic Management. Youll be working for a varied range of clients and, dealing with various RCAs throughout New Zealand. Youll have the flexibility to work from home or within an office space depending on your...

  • Starting Well Lead

    7 months ago


    New Zealand Te Whatu Ora - Health New Zealand Full time

    Join Te Whatu Ora at a key time of change where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health system. This is mahi that will improve the health and well-being of everyone in Aotearoa, and we've got an opportunity for you to be part of it. **Te whiwhinga mahi | The...