Japan Regulatory Affairs Specialist

Job not on LinkedIn

🕒 March 25

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2011

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🎯 Recruiter

Pharmaceuticals • Healthcare Insurance • Recruitment

Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.

📋 Description

• Partner with Country RA (CRA), AWC, QA, SMEs, and partner companies to ensure compliant artwork development. • Manage SharePoint structure, documentation accuracy, and version control. • Support CRA as 1st/2nd RA reviewer. • Attend weekly Tier-1 meetings and bi-weekly meetings with local CRAs. • Retrieve CRB/Tier-1 decisions and required inputs. • Prepare meeting materials, and join artwork/regulatory discussions. • Prepare QRD Checklists and Annotated PDFs for each artwork. • Determine workflow type (Concept / Mock-Up / Production) and initiate Artwork Request. • Provide RA comments, coordinate 2nd RA reviews, and manage regulatory submissions/approvals. • Monitor workflow notifications and address queries from PC, AWC, CRA, and SMEs. • Perform regulatory QC to ensure alignment with Annotated PDF & QRD, no unauthorized changes, and barcode encoding confirmed by QA. • Coordinate internal reviews (e.g., Marketing, ExM).

🎯 Requirements

• Regulatory knowledge (Japan artworks, labeling, packaging compliance) • Experience with GLAMS or other artwork management systems • File/document management (SharePoint proficiency) • Understanding of QRD, annotated PDFs, packaging components • Ability to interpret regulatory decisions and change controls

🏖️ Benefits

• Remote Work / Improved work-life balance • Open for Junior candidates as well ( This role will allow the person to gain experience while supporting the main person in charge.) • Competitive Salary • Work in an international / Global environment