Senior Regulatory CMC Manager — Japan Submissions

BeiGene; Saxnäs; On-site; SEK 900,000 - 1,300,000; Full time

Benefits offered by this job

Performance-based bonus

Company shares

Learning & development

Benefits program

Job summary

BeOne is seeking an experienced regulatory professional to manage CMC submissions for Japan, coordinating with global teams to develop strategies and timelines. You will draft, translate, and maintain CTD modules (M1.2/M2.3) in English/Japanese and support PMDA interactions.

The role requires 3+ years in pharma/biotech regulatory CMC, strong writing skills, and familiarity with ICH and GMP. The position offers competitive compensation, shares, and development opportunities in a fast-paced,

Qualifications

• 3+ years of related pharmaceutical or biotech regulatory CMC experience.
• Experience in authoring complex regulatory CTD sections (M1.2/M2.3).
• Excellent written and verbal communication skills.

Responsibilities

• Lead CMC regulatory submissions for Japan, coordinating with Global regulatory CMC teams.
• Develop and implement Japan-specific CMC submission strategies and timelines.
• Prepare Japan CTD M1.2/M2.3 with Global teams in English/Japanese.

Skills

Regulatory CMC experience

Excellent communication

Detail-oriented

Self-motivated

Education

BA/BS Degree in scientific disciplines

MS/PhD preferred

Tools

MS Office

Veeva Vault

Job description

BeOne is seeking an experienced regulatory professional to manage CMC submissions for Japan, coordinating with global teams to develop strategies and timelines. You will draft, translate, and maintain CTD modules (M1.2/M2.3) in English/Japanese and support PMDA interactions.

The role requires 3+ years in pharma/biotech regulatory CMC, strong writing skills, and familiarity with ICH and GMP. The position offers competitive compensation, shares, and development opportunities in a fast-paced,