Regulatory Project Manager to AstraZeneca in Gothenburg
MODIS Life Science is now looking for a Regulatory Project Manager consultant to AstraZeneca in Gothenburg. This is a 1-year consultancy assignment start ending of 2019/beginning of 2020 running until 2020-12-31. Send your application no later than October 22nd.
AstraZeneca is a science-led, global biopharmaceutical company, with a focused portfolio in core therapies. We are committed to improving the health and lives of people across the globe, through our broad research and development platform, and a growing late-stage pipeline. Working in over 100 countries, we have strength in emerging markets, and our medicines are used by millions of patients and clinicians worldwide.
We are now looking to recruit Regulatory Project Managers to the Regulatory Respiratory, Inflammation and Autoimmunity (RIA) team within BioPharmaceuticals in Gothenburg. Our team is accountable for end to end regulatory project delivery, from phase I to marketed products, in line with business priorities, providing regulatory expertise, efficient project management and strong leadership.
About the role
The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned regulatory procedures and submissions. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to regulatory project teams, and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
- Project manage (plan, prepare, coordinate and deliver) submission in accordance with agreed plans.
- Develop, execute and maintain submission plans and proactively provide status updates to designated stakeholders.
- Identify potential regulatory risks to the operational plans and propose options to mitigate these.
- If required, lead sub-teams to deliver regulatory submissions.
- Provide operational regulatory input and guidance with respect to regulatory submissions.
- Ensure that appropriate, up-to-date records are maintained for compliance.
- Use and share best practices, when handling various applications and procedures.
Minimum Requirements – Education and Experience
- Relevant University Degree in Science or related discipline
- Regulatory experience, minimum 1 year, within the biopharmaceutical industry, or at a health authority, or other relevant experience
- General knowledge of drug development
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
Skills and capabilities
- Excellent written and verbal communication skills
- Cultural awareness
- Proficiency with common project management and document management tools
- Ability to work independently and as part of a team
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend actions