RA SPECIALIST

Johnson & Johnson is currently seeking a RA Specialist located in Singapore.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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om/ Position Summary As a RA Specialist, coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies.
Ensures compliance with regulatory agency regulations and interpretations.
Prepares responses to regulatory agencies' questions and other correspondence.
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Provides solutions to a variety of problems of moderate scope and complexity.
Organizes and maintains reporting schedules of new product registration, changes in products, projects, etc.
As an APJ Veeva Coordinator, primary responsibility is to ensure the smooth operation and effective use of the Veeva system within the organization.
The Veeva system is a copy clearance approval system for advertisement and promotional material, and local labelling materials in Johnson & Johnson Vision.
In this role, you will be responsible for managing and coordinating various aspects of the Veeva system to support sales, marketing, and regulatory activities.
Responsible for APJ Vision advertisement and promotional materials, and local labelling materials.
Ensure the smooth operation and optimal utilization of the VEEVA system while managing and coordinating various aspects of the VEEVA system to support APAC Vision advertisement and promotional materials, and local labelling.
Ensure compliance to applicable JJV Copy Approval procedure(s) Enhancing efficiency, establishing streamlined procedure(s), and integrating the Vision procedure(s) will be the key focus areas through the APAC copy review and labelling approval process project.
Responsibilities.
VEEVA Coordinator System Administration/Coordination.
Serve as the main point of contact for Veeva system administration/Coordination, including user access management, security settings, and configuration updates.
User Support and Guide/Training.
Provide support for Veeva system users, including troubleshooting issues, answering inquiries, and conducting training sessions to ensure proper system utilization.
Data Management.
Oversee the accuracy and integrity of data within the Veeva system, including data entry, data maintenance, and data cleansing activities.
Reporting and Analytics.
Generate and distribute reports and analytics from the Veeva system to support sales and marketing teams in assessing performance, tracking metrics, and identifying trends.
Continuous Improvement.
Stay updated with changes and enhancements in the Veeva system and make recommendations for process improvements, system updates, and user experience enhancements.
Collaboration.
Collaborate with cross-functional teams, including sales, marketing, and IT, to streamline processes, align strategies, and ensure system integration with other business applications.
Documentation and Training Materials.
Create and maintain user documentation, training materials, and standard operating procedures to guide users in utilizing the Veeva system effectively.
Provide relevant trainings to the users necessarily.
Compliance and Governance.
Ensure compliance with industry regulations and internal policies related to data privacy, data protection, and information security within the Veeva system.
Vendor Management.
Collaborate with Veeva system vendors to address technical issues, system updates, and service enhancements as needed.
RA Specialist Prepares, submits, and monitors applications of new products, changes in approved products, and KGMP.
Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management.
Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with limited supervision.
Follow-up of mandatory requirements for registration.
local certificates, importation of samples, local testing, etc.
with limited supervision.
Ensures Korean label contents and approves the final Korean label artwork.
Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager.
Provides training and limited supervision of contract resources, as needed.
Supports and contributes to team, company, regional, global, cross-sector projects.
Shares best practices and learnings with the team in terms of RA processes and templates, product registration, projects, etc.
Leverages experience and learnings from the past to make reasonable decisions in challenging situations.
Understands business environment and business strategies and develops effective and results-oriented regulatory strategic plans that are in line with business objectives.
Manages specific project steps to meet milestones independently or with limited supervision.
Understands trends in the healthcare environment, changes in external marketplace, and competitors’ tendency and the influence of social, economic, and political factors on business and regulatory environment.
Effectively manages priorities and strongly collaborates with stakeholders to make the best possible decision.
Consistently manages large amount of changing, complex, ambiguous information and makes reasonable decisions in a timely manner.
Engages with external stakeholders and demonstrates conviction, proactivity, and persistence especially when influencing others and overcoming resistance.
Creates compelling positions in negotiations that build support and consensus with key stakeholders.
Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
Creates and delivers verbal and written communication with highlighting the most pertinent information for targeted stakeholders.
Supports stakeholders to take actions if needed.
Acts with speed, agility and accountability in decision making and balances short and long-term decisions and activities.
Demonstrates an enterprise-wide mindset.
Experiments and learns from trying new approaches and applying the new ideas from insights - Qualifications Bachelor's degree with at least 3 to 5 years of experience Expert knowledge, understanding, and application of principles, concepts, and practice of regional governmental regulations.
Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
Excellent organizational, communication, negotiation, and interpersonal skills.
Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.
Previous experience working with Veeva system administration is highly preferred.
Familiarity with the medical device industry and understanding of regulations Strong technical aptitude and ability to learn new software systems quickly.
Excellent problem-solving skills with strong attention to detail.
Effective communication and interpersonal skills to provide support and training to Veeva system users.
Ability to manage multiple tasks, prioritize effectively, and meet deadlines.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.