Experienced Scientist - CMC Regulatory Science

1w1 week ago

Johnson & Johnson

Allschwil, CH · Full-time · CHF 130,000 – CHF 170,000

About this role

Johnson & Johnson Innovative Medicine develops treatments and finds cures, pioneering from lab to life while championing patients. The Experienced Scientist Regulatory supports team members in Chemistry, Manufacturing and Controls within Global Regulatory Affairs. This role ensures alignment with global strategies through collaboration.

Day-to-day involves assisting in CMC regulatory strategy alignment with global, regional, and commercial plans. Develop CMC content and dossier plans under supervision of senior CMC RA personnel. Prepare global dossiers, variations, renewals, and responses to health authority questions.

Interact with professional colleagues including CMC/Supply Chain team members, Therapeutic Area Leaders, and GRA management as needs dictate. Work with other CMC RA personnel to manage and resolve issues. Coordinate and manage country-specific documents for global submissions.

Execute oversight of global submission plans and timing. Contribute to implementing CMC regulatory strategies by partnering with CMC RA personnel. Escalate issues affecting registration, compliance, and supply to management.

Requirements

Knowledge of Chemistry, Manufacturing and Controls (CMC) regulatory requirements
Familiarity with global regulatory strategies and dossier preparation
Experience supporting CMC submissions and variations to Health Authorities
Ability to align CMC strategies with overall global regulatory plans
Understanding of health authority interactions and responses
Collaboration skills with cross-functional teams in regulatory affairs

Responsibilities

Support team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs
Assist in ensuring the CMC regulatory strategy aligns with global/regional/commercial regulatory strategy
Develop CMC content and dossier plans under supervision/collaboration of senior CMC RA personnel
Assist in preparation of global dossiers/variations for submission to Health Authorities
Assist with CMC submissions for renewals, annual product submissions, and questions from health authorities
Coordinate, compile, and manage CMC country-specific documents for global submissions
Execute oversight of the global submission plan and timing
Assist in preparing responses to HA questions or communications in alignment with global product strategy