Manager, Rmc Liaison

5 days ago

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 the local execution of submissions. The role also has a dual responsibility to work as the AP Regulatory Lead (RL) for assigned products in the Established Products portfolio.

The position reports to the RMC Planning and Operations Lead.

**RESPONSIBILITIES - RMC LIAISON**:

- Manage RMC Submissions for assigned therapeutic area/s, and support RMC submissions for other therapeutic area/s as and when required
- Receive dossier/project from RMC Planning and Operations Lead
- Review core dossiers received from global and confirm impacted markets.
- Review core dossiers and identify and raise potential issues with global team and/or the AP RL
- Create and maintain each market’s submission plan in the RMC Tracker and planning tool
- Collaborate with and support RMC LOC Submission Professionals to ensure submission deadlines are met for AP markets
- Support requests for additional local country-specific dossier requirements
- Identify the need for local label deviations (LLDs) and co-ordinate LLD requests for submissions in RMC scope
- Support Health Authority Queries (HAQs) for submissions in RMC scope
- In order to maintain the highest standards of compliance, collaborate closely with the RMC Systems Team, Compliance & Systems Manager, and RMC Submissions Team:

- Ensure delayed submissions are valid and any request for extension is approved prior to the original submission due date
- Ensure RMC LOC Submissions Professionals are adequately trained in RMC processes and adhere to these when working on in-scope submissions
- Assist with reference country monitoring processes across the region, specifically when an approval is received in an AP market and there is an AP-dependent market
- Contribute to the maintenance of the RMC Working Guidelines and identify when process updates or improvements are needed
- Act as regional point of contact for specific markets as RMC Partner, to triage and discuss process changes, local regulation updates and share feedback

**RESPONSIBILITIES - AP REGULATORY LEAD (Established Products)**:
Provides regional regulatory support for activities related with assigned products in the EP Portfolio. Works with regional management, global team members (e.g. Strategic Implementation Leader) and LOC regulatory teams to define and implement the regional and local strategy for assigned products.

Is accountable for the development of the regional regulatory strategy and ensures the implementation of multi-national/regional regulatory and strategies that optimize registration, and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

**Regulatory Strategy and Expertise**
- Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
- Participates as a standing member of the GRT if applicable; supports the GRT by providing strategic regional input into registration and lifecycle management.
- Provides input to post-registration activities, including labeling changes.
- Provide regional implementation and regulatory-based advice on new and updated Company Core Data Sheets.
- Maintains expert knowledge in regional and product-specific regulatory requirements.
- Supports Health Authority, LOC, and Business Partner Interactions.
- Manages regulatory interactions with LOCs and regional functions.
- Facilitates discussions with LOCs on regional or global regulatory issues, as required.
- Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners.
- Provides guidance to LOCs to determine timing and strategy for HA meetings. Participates in preparations for interactions with HAs and assists LOCs with these interactions.
- Under supervision and/or supported by a supervisor, provides guidance to LOCs on development of strategies to accelerate submissions/approvals.

**Regulatory Submissions**
- Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
- Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions
- Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance.
- Reviews and provides input to critical submission doc

  • Regional Liaison Lead

    7 months ago

    New Zealand New Zealand Government Full time

    Permanent, full-time role - Location negotiable - Have a direct impact on the delivery of barrier-free access to education Help shape the future of Education He mea tārai e mātou te mātauranga kia rangatira ai, kia mana taurite ai ōna huanga We work to shape an education system that delivers equitable and excellent outcomes At Te Tāhuhu o te...

  • Customer Service Liaison

    7 months ago

    New Zealand Muster Recruit Full time

    **The Opportunity** We are looking for **Customer Service Liaisons** With roles in both **Grey Lynn** and **Mt Wellington** our clients are **automotive industry **leaders whose focus is developing and maintaining relationships with their customer bases. **This is an exciting opportunity to join a dynamic, proactive, customer focused team based in a call...

  • Registered Nurses

    7 months ago

    New Zealand CareJobz Recruitment Full time

    **Registered Nurses - Psychiatric Liaison** **Auckland Based** **Excellent renuemeration** **Full and Part Time Positions available** We are a leading recruitment company dedicated to providing the best health care to the communities of North and West Auckland and the Rodney District. We have an exciting opportunity for experienced Mental Health Nurses...

  • Senior Contract Liaison Manager, National Systems

    7 months ago

    New Zealand Te Whatu Ora - Health New Zealand Full time

    **Contribute to transforming the future of health**: - **Flexible working supported to balance your work and lifestyle**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health...

  • Contract Liaison Coordinator, Contracting and

    6 months ago

    New Zealand Health New Zealand - Te Whatu Ora Full time

    **Contribute to transforming the future of health** - **Flexible working supported to balance your work and lifestyle**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health...

  • Engineering Manager

    4 days ago

    New Zealand Grada Recruitment Full time

    **Grada Recruitment** is working with a well-known Geotechnical Design and Build Contractor based in Auckland but working nationally. Our client is looking for a Senior or Principal Geotechnical Design Engineer to run the company's design function and develop a team. This is a new role driven by increasing workload and strategic advantage for delivering...

  • Venue Manager

    7 months ago

    New Zealand Epic Hospitality Full time

    **JOB DESCRIPTION** **Position Title** Venue Manager Eva Pub **Objective of position** To effect the overall smooth and efficient operation of the business with the primary focus of fostering an ongoing positive working relationship with the customer base, staff and suppliers. To maximise sales volumes and profitability. To train and manage an...

  • Pre-construction Manager

    6 months ago

    New Zealand Cook Brothers Construction Full time

    **Does this sound like you?**: You are a dynamic and driven professional with a competitive spirit and a passion for building. Thriving in fast-paced environments, you are motivated by challenges and bring over 5 years of proven experience in bid or project management. You approach tenders and projects with a creative and innovative mindset, contributing...

  • Hotel Manager

    4 days ago

    New Zealand mynewjob Ltd Full time

    Our client is a family owned hotel in the bustling country town of Reefton, population 1000. The hotel is popular with locals tourists and travellers, offering accommodation and meals. The 45 seat restaurant is open 7 evenings a week, as well as catering for client functions and hotel guest breakfast. **The Opportunity** This is an opportunity to join a...

  • Cleaner

    9 months ago

    New Zealand Gurukirpa Wellington Limited Full time

    **Job Requirements**: - Delivering day to day commercial and residential quality cleaning services on client sites. - Carpet cleaning and other services. - Must be physically able to work within a manual handling environment. - Client liaison and relationship building - Positive and friendly customer focus - Proactive an eye for detail - Committed and...

  • Change Manager

    7 months ago

    New Zealand New Zealand Police Full time

    Based at Police National Headquarters Police Employee Fixed term - Full Time NAV JR 4804166 E tῡ ki te kei o te waka, kia pakia koe e ngā ngaru o te wā. Stand at the stern of the canoe and feel the spray of the future biting at your face Mō te tūnga | About the role As a Change Manager within the Transformation and Change team, you will be a...

  • Bdm - Information Security

    3 days ago

    New Zealand Mergodon Ltd Full time

    **Mergodon Limited is a New Zealand-based information technology company where we are passionate about helping people transform their ideas into reality and safe solutions.** **We are currently looking for a Business Development Manager - Cyber Security to boost our Cyber Security side on the Hungarian market while focusing on the other side of the...

  • Press Secretary

    6 months ago

    New Zealand Department of Internal Affairs NZ Full time

    **Type**:Events Based **Hours**:Full time **Location**:Wellington **Business Group**:Ministerial Services **Branch**:Enterprise Partnerships The Hon Matt Doocey, Minister for ACC, Minister for Mental Health, Minister for Tourism and Hospitality, Minister for Youth, Associate Minister of Health and Associate Minister of Transport, is seeking a motivated and...

  • Personal Assistant

    3 days ago

    New Zealand LOVENZ LTD Full time

    **Responsibilities**: Manage the directors schedule, including coordinating meetings and appointments, ensuring timely reminders for important deadlines, and making travel arrangements Attend meetings as required, prepare reports, briefing notes, memoranda, file notes, presentations, and other materials etc Take dictation of letters and other documents and...

  • Mental Health Professional

    7 months ago

    New Zealand CareJobz Recruitment Full time

    **Registered Nurse or Occupational Therapist** **Location: Hutt Valley** **Service: Infant, Child, Adolescent** **Contract: Permanent 1.0 and 0.6 FTE available** **About the Position** Our client has an exciting opportunity available in the Hutt Valley for professionals specialising in Infant, Child, Adolescent, and Family Mental Health Support. We are...

  • Project Engineer

    7 days ago

    New Zealand Grada Recruitment Full time

    **Engineers Earthworks** Grada Recruitment is currently recruiting three roles for Project Engineers with a great understanding of Earthworks and Drainage, and Three Waters projects. We are working with two well-known and respected Earthworks & Civil contractors who are responsible for delivering a high volume of Auckland's housing and green space...

  • Clinical Head of Department, Mental Health, Adult

    7 months ago

    New Zealand Te Whatu Ora – Health New Zealand Te Tai Tokerau Full time

    **Adult Whangarei and Kaipara Mental Health and Addictions services (0.2FTE)** Te Whatu Ora Te Tai Tokerau advocates for affirmative action and actively seeks Maori into our workforce to reflect the community we serve. We are committed to Te Tiriti o Waitangi and hold stewardship for equitable health outcomes for Māori as Tāngata Whenua as the highest...

  • Pastry Cook

    6 days ago

    New Zealand SATURN GROUP NEW ZEALAND LIMITED Full time

    Gogo Music Cafe restaurant was established in 2016 and since then has attained a reputation for quality Chinese cuisine in North Shore, Auckland. We serve a wide range of traditional Chinese dishes and pastries, especially Chinese BBQ. To meet the increasing kitchen demand, we are looking for two experienced pastry cooks (Chinese Cuisine) - Prepare and make...

  • Junior Accounts and Administrative Support

    3 days ago

    New Zealand Alpha Personnel Recruitment Ltd Full time

    **The Client**: We are delighted to represent our client who is aNew Zealand-owned company and is one of NZs premium cafe groups.As this is a permanent role you will need to hold a permanent residency or have citizenship in New Zealand. This role would be perfect for a person with a strong customer services background who had exposure to billings and...

  • Regional Sales Manager

    7 months ago

    New Zealand Dentsply Sirona Full time

    Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable...