Global Regulatory Affairs Lead: Drug Submissions & Strategy

Cari

Søborg

Remote

DKK 651,000 - 957,000

Full time

9 days ago

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Job summary

Cari is seeking a Senior Regulatory Affairs Professional to guide global regulatory submissions and shape Health Authority interactions across the product lifecycle. You will translate complex regulatory requirements into clear strategy, collaborate with research, development, safety, clinical operations and commercial teams, and deliver outcomes with global impact.

The role requires a strong life sciences background, EU/US regulatory experience, excellent English communication, and the ability

Qualifications

Master’s degree in life sciences plus 5–7 years of relevant experience, or PhD with 3–4 years.
Or bachelor’s in life sciences with 8–11 years of relevant experience.
Experience with regulatory submissions in EU/US/China/Japan.
Knowledge of drug development lifecycle, labeling, and Health Authority interactions.
Strong written and spoken English; ability to communicate complex information clearly.
Ability to work independently, set priorities, and manage multiple deliverables.

Responsibilities

Plan and coordinate global regulatory submissions, including MAAs, CTAs, and lifecycle submissions.
Apply regulatory intelligence to develop submission strategies, plans, content structures and timelines.
Prepare regulatory files and coordinate document creation, review, and submission.
Manage responses, commitments and follow-up activities arising from Health Authority interactions.
Plan and support interactions with Health Authorities, including meetings and briefing packages.
Develop and maintain core labeling, including the Company Core Data Sheet and European labeling.
Contribute to global regulatory strategies and identify opportunities to improve methods and processes.
Provide regulatory guidance to stakeholders and mentor less-experienced colleagues.