GS APAC Regulatory Information Administrator Lead

Job Function:*
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Bangalore, Karnataka, India, Paranaque, National Capital Region (Manila), Philippines
Job Description:

Global Services Manila - Strategic Solutions and Commercial Services

"Reimagine the possibilities" at Johnson and Johnson Global Services! We live this motto every day by creating game-changing business solutions for the world's largest and most broadly-based healthcare company.

As a member of our Global Services team, you will have exclusive access to a network of professionals located in over 60 countries. This new network will help you build on your current skills and explore opportunities to grow your career in J&J.

At J&J Global Services, we value ideas for innovation and improvement and are committed to diversity and inclusion. Together we will reimagine business processes to become more effective, more efficient, and improve customer experience. We are proud to be an equal opportunity employer. The Global Services organization provides best-in-class, cost-effective services, and compliance-in a J&J way-to our Operating Companies around the world.

This GS APAC Regulatory Information Administrator Lead role will be part of the Global Services in the Strategic Solutions and Commercial Services (SCS) function, supporting the APAC MedTech Regulatory Affairs team.

Johnson & Johnson MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://https://www.jnj.com/medtech

The Asia Pacific Regulatory Affairs (RA) are responsible for regulatory activities of MedTech portfolio.

GS APAC Regulatory Information Administrator Lead

As a Regulatory Information Administrator Lead, you will be responsible for supporting the RA system called "MDRiM" for data management in Asia Pacific MedTech. You will play a critical role in improving data quality, transparency, and efficiency in APAC regulatory performance. You will lead the project management and supervise the set-up and stabilization of the processes; while gathering learnings to aid in the potential future scale-up of the team.

Key Responsibilities:

• Monitor and complete regulatory impact assessments in the MDRiM system, including the maintenance of license information.

• Identify and extract the required information from various data sources and conduct analyses as per requests.

• Create and maintain trackers and databases to ensure data accuracy and integrity.

• Coordinate with APAC markets to ensure accurate data representation.

• Create and maintain local/regional strategies and RA actions in MDRiM based on requests.

• Participate in process improvement initiatives.

• Support RA forecast and execution planning activities to keep MDRiM and the other database consistent.

• Be the direct manager of the PG24 GS APAC Regulatory Information Administrator

• Be the key liaison between APAC business stakeholders and GS stakeholders

Required Skills:

• Ability to precisely follow step-by-step guides without deviating from instructions unless confirmed by the appropriate team.

• Proficiency in English with effective communication skills to interact with multiple local RA users for query clarifications.

• Strong capability in operating CSV, Excel, and Power BI, along with an understanding of relational database management systems.

• Ability to escalate issues appropriately to supervisors as needed.

Qualifications & Background:

Education

• A minimum of a bachelor's degree is required, with a concentration in Business, Finance, Sales or Marketing preferred.

Other Requirements

• 6+ years of professional experience, preferably within the medical device, surgical, or healthcare industry

• At least 2+ years in managing others

• Project Management and ability to navigate ambiguity

• Operate with discipline and sense of urgency.

• Strong database management skills and a team-oriented mindset.

• Experience in data administration within the medical field.

• Ability to work effectively in a cross-functional environment and build support across a complex set of stakeholders.

• Strong attention to detail and a commitment to compliance and data integrity

• Ability to execute plans with attention to detail.

Preferred

• Experience on Regulatory, Quality or Clinical in Medical device or pharmaceutical fields

• Experience in a shared services center of a multinational corporation is desirable.

Working Hours: 8am SGT - 5pm SGT

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.