Regulatory Project Manager

The Regulatory Project Manager (RPM) is a member of the Global Regulatory Execution Team (GRET) and works for nominated products/projects to plan, prepare and deliver both simple and increasingly complex submissions to achieve the following across a range of markets:
Successful regulatory approvals
Optimum market access
Maintenance of product licenses
Regulatory compliance

Accountabilities:
Project manage (plan, prepare, coordinate and deliver) submission in accordance with agreed plans
Support the Lead RPM with planning, risk identification/mitigation and status updates of assigned deliverables, as well as milestones achieved.
If required lead sub-teams to deliver regulatory major/complex submissions
Provide operational regulatory input and guidance in cross-functional teams.
Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program.
Delivers project assignments supporting the business, e.g., representation on global cross-functional task forces or regulatory work streams.
Ensure that appropriate, up-to-date records are maintained for compliance.

Minimum experience
University Degree in Science or related discipline
Project Management experience
Relevant regulatory experience or experience elsewhere in Pharmaceutical Industry e.g. Marketing Company, Health Authority, R&D or Operations
Excellent written and verbal communication skills
Thorough knowledge of the drug development process
Scientific knowledge sufficient to understand all aspects of regulatory issues

Preferred Experience
Knowledge of ...

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