Global Regulatory Submissions Specialist

Regulatory Jobs; Santa Clara (CA); On-site; USD 58,000 - 93,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Vacation 120 hours per year

Sick time 40 hours per year

13 holidays per year

Parental Leave

Job summary

Johnson & Johnson is hiring a Regulatory Affairs Specialist, Ops for our Santa Clara, CA location. You will manage global regulatory submissions, maintain documentation, and support regulatory infrastructure across markets.

The role requires a bachelor’s degree and at least 2 years in regulatory roles within healthcare, with strong MS Word/SharePoint/Excel skills and meticulous attention to detail. Johnson & Johnson is an Equal Opportunity Employer.

Qualifications

• Bachelor's degree or equivalent; science/engineering/medical fields preferred.
• Minimum 2 years of regulatory experience in healthcare.
• Proficient with MS Word, SharePoint, Excel, Adobe and PowerPoint; Word Macros/Styles preferred.
• Strong digital aptitude and ability to learn new platforms quickly.
• Excellent verbal and written communication; detail oriented.

Responsibilities

• Publish worldwide regulatory submissions in line with geography-specific requirements.
• Track licenses, registrations, and renewal documentation.
• Archive submissions and maintain controlled documentation repository.
• Author and route document changes via electronic document control system.
• Provide country-specific regulatory support and notarizations as needed.
• Contribute to process improvements within Regulatory Operations.

Skills

Communication

Analytical thinking

Organizational skills

Time management

Problem solving

Education

Bachelor's degree or equivalent

Tools

MS Word

SharePoint

Excel

Adobe

PowerPoint

Word Macros

Job description

Johnson & Johnson is hiring a Regulatory Affairs Specialist, Ops for our Santa Clara, CA location. You will manage global regulatory submissions, maintain documentation, and support regulatory infrastructure across markets.

The role requires a bachelor’s degree and at least 2 years in regulatory roles within healthcare, with strong MS Word/SharePoint/Excel skills and meticulous attention to detail. Johnson & Johnson is an Equal Opportunity Employer.