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Senior Manager, Css Rpl Aspac, Perth, Johnson & Johnson

Published 2022-09-24
Expires 2022-10-24
ID #1181980394
Free
Senior Manager, Css Rpl Aspac, Perth, Johnson & Johnson
Australia, Perth, Perth,
Published September 24, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Senior manager, css rpl aspac


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Description

Overall Responsibilities

Represent regional regulatory affairs to lead and shape the communication for key projects and critical issues, including but not limited to new product launch/early evaluation strategies, product lifecycle management & process excellence projects, by partnering with local RA, global RA and other functional partners (e.g. commercial, supply chain, quality, deliver, R&D) to ensure regulatory requirements are well understood and relative actions will be taken to secure launch excellence and/or business continuity and compliance;

As regional DRI, oversee the forecast planning, lead the prioritization and support the execution and issue resolution of regulatory cycle plans in ASPAC by closely collaborating with global RA;

Keep abreast of knowledge on ASPAC regulations and their evolutions; Support local RA team to assess impacts and make regulatory recommendation to related stakeholders in region and global;

Regulatory lead for A&D projects for ASPAC and as partner supporting global A&D regulatory WS lead and regional cross functional leads and cluster/countries to define a comprehensive strategy, planning and business goals; Drive and ensure regulatory strategy and planning execution.

Functional & Technical Competencies

Facilitate conversation between global RA and local RA aligned registration plan based on GSM strategy and consolidate AP region markets regulatory annual cycle planning for NPD/NPI and LCM. Support country to fulfill registration requests especially for urgent and critical submissions.

As a point of contact person, strategically collaborate with regional marketing and region SC on NPI/NPD, LCM submission priority and registration timeline based on alignment with each market and regulatory pathway. Represent regulatory affairs in regional SC S&OP meeting and plan transformation discussion to input regulatory implication.

Lead process discussion and improvement via using metrics and reports

Support and provide regulatory assessment and interpret regulatory implication to supply chain to work out scenario plan based on registration lead time, BP/S&OP delivery

Ensure RPRC compliance capability 100% of time with accurate collaboration with country and MDM partners. Alert & partner to mitigate with regional SC of any changes/disruption across the franchise SC impacting product availability and service reliability due to regulatory causals

Support and input regulatory insights to support key projects initiated by global or other non-regulatory function in region.

Lead AP region A&D projects as applicable and ensure global strategy and planning execute in place.

Leadership Competencies

CONNECT by cultivating strong internal partnerships and collaborations through transparent and constructive conversations, contributing to high-performing team in region

SHAPE by identifying and communicating meaningful risks, taking appropriate action and demonstrating an awareness of the highest standards of quality and compliance.

LEAD by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions.

DELIVER by understanding how one’s own work impacts the franchise and use this understanding to make effective decisions and take actions.

Qualifications

Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration

Advanced degree in a technical, medical, or business area is desirable

10+ years of business experience in regulatory and industry. Solid regulatory knowledge and working experiences to obtain regulatory approval / clearance of new or modified medical devices

Fluent in English (both written and verbal fluency)

Strong business acumen, understanding of key global business trends

Strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously

Proven ability to think strategically and to translate strategic directives into tactical initiatives

Excellent executive presentation skills, able to communicate complex ideas clearly and concisely and able to respectfully question and or challenges others to think through problems, improvement opportunities, solutions and plans

Strong leadership skills and technical analytical skills, operates as leader with understanding and appreciation for regional differences

Relationship management collaboration skills

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Primary Location
Singapore-Singapore-Singapore-
Other Locations
Asia Pacific-New Zealand, Asia Pacific-Thailand, Asia Pacific-Australia, Asia Pacific-Vietnam, Asia Pacific-India, Asia Pacific-Indonesia, Asia Pacific-Japan, Asia Pacific-Taiwan, Asia Pacific-South Korea, Asia Pacific-China, Asia Pacific-Malaysia, Asia Pacific-China-Hong Kong S.A.R., Asia Pacific-Philippines
Organization
Johnson & Johnson Pte. Ltd.

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    Registered on October 7, 2017

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    Finance is a field that deals with the study of investments. It includes the dynamics of assets and liabilities over time under conditions of different degrees of uncertainty and risk. Finance can also be defined as the science of money management. Finance aims to price assets based on their risk level and their expected rate of return. Finance can be broken into three different sub-categories: public finance, corporate finance and personal finance.


    Perth ( (listen) PURTH) is the capital and largest city of the Australian state of Western Australia (WA). It is named after the city of Perth, Scotland and is Australia's fourth-most populous city, with a population of 2.14 million living in Greater Perth. Perth is part of the South West Land Division of Western Australia, with most of the metropolitan area on the Swan Coastal Plain, land area between the Indian Ocean and the Darling Scarp. The first areas settled were on the Swan River at Guildford, with the city's central business district and port (Fremantle) both later founded downriver. Captain James Stirling founded Perth in 1829 as the administrative centre of the Swan River Colony. It gained city status (currently vested in the smaller City of Perth) in 1856 and was promoted to the status of a Lord Mayorality in 1929. The city inherited its name due to the influence of Sir George Murray, then Member of Parliament for Perthshire and Secretary of State for War and the Colonies. The city's population increased substantially as a result of the Western Australian gold rushes in the late 19th century. During Australia's involvement in World War II, Fremantle served as a base for submarines operating in the Pacific Theatre, and a US Navy Catalina flying boat fleet was based at Matilda Bay. An influx of immigrants after the war, predominantly from Britain, Italy, Greece, and Yugoslavia, led to rapid population growth. This was followed by a surge in economic activity flowing from several mining booms in the late 20th and early 21st centuries that saw Perth become the regional headquarters for several large mining operations. As part of Perth's role as the capital of Western Australia, the state's Parliament and Supreme Court are in the city, as is Government House, the residence of the Governor of Western Australia. Perth came seventh in the Economist Intelligence Unit's August 2016 list of the world's most liveable cities and was classified by the Globalization and World Cities Research Network in 2010 as a Beta world city. It hosted the 1962 Commonwealth Games. Perth is divided into 30 local government areas and 250 suburbs, stretching from Two Rocks in the north to Singleton in the south, and east inland to The Lakes. Outside of the main CBD, important urban centres within Perth include Armadale, Fremantle, Joondalup, Midland and Rockingham. Most of those were originally established as separate settlements and retained a distinct identity after being subsumed into the wider metropolitan area. Mandurah, Western Australia's second-largest city, has in recent years formed a conurbation with Perth along the coast, though for most purposes it is still considered a separate city.

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