Global Regulatory Operations Specialist — eCTD & Submissions

Immedica Pharma AB; Stockholms kommun; Hybrid; SEK 520,000 - 700,000; Full time

Benefits offered by this job

Hybrid work model

Office in Stockholm

Job summary

Immedica Pharma AB in Stockholm seeks a Regulatory Operations Associate to strengthen Global Regulatory Operations. You will help manage submissions, data quality, and regulatory systems across the product lifecycle.

The role reports to the Regulatory Director, works with international partners and internal teams, and offers a hybrid setup from our Stockholm HQ. Fluency in English is required; Swedish is a plus.

Qualifications

• University degree in life sciences, pharmacy, information management or computer science.
• Experience in pharma/biotech industry or CRO is beneficial.
• Experience in regulatory operations, eCTD publishing, and health authority gateways (EMA Gateway, CESP, FDA ESG NextGen) is advantageous.

Responsibilities

• Global regulatory submissions, variations, renewals, and lifecycle maintenance.
• Plan and perform eCTD publishing and electronic submission.
• Manage submissions through health authority gateways and portals.
• Coordinate regulatory document management, templates, and archiving.
• Maintain regulatory data in RIMS and support system improvements.

Skills

Regulatory operations

eCTD publishing

Regulatory information management

Regulatory submission

Health authority portals

Data quality

Cross-functional collaboration

English proficiency

Education

Relevant university degree (life sciences, pharmacy, information management, computer science)

Tools

Veeva RIM

LifeSphere

Lorenz

EXTEDO

Job description

Immedica Pharma AB in Stockholm seeks a Regulatory Operations Associate to strengthen Global Regulatory Operations. You will help manage submissions, data quality, and regulatory systems across the product lifecycle.

The role reports to the Regulatory Director, works with international partners and internal teams, and offers a hybrid setup from our Stockholm HQ. Fluency in English is required; Swedish is a plus.