SENIOR REGULATORY OFFICER

Senior Regulatory Affairs Officer Introduction to role Within the Italian Marketing Company, you will achieve and maintain regulatory authorizations for new and existing products in compliance with local legislation and Marketing Company Code/Standard Operating Procedures (SOPs).
You will ensure the maintenance and compliance to GRP, GMP, Local and Global SOPs, MC Regulatory Process, and Quality Manual of the Italian Marketing Company, as well as Italian and European regulations and legislations.
Accountabilities - Manage the registration application for new products, new indications, and extensions, in compliance with up-to-date national and EU legislation and within the agreed deadlines.
- Guarantee the correct maintenance of registered products (renewals, quality and safety updates, labelling requirements, and implementation).
- Interact with Italian Regulatory Authorities to resolve any product-related issues (including shortages) to maximize the effectiveness of regulatory authorization with the support of the Line Manager, if necessary.
- Ensure compliance to GRP with specific responsibilities including supervising regulatory knowledge traceability, proper archiving of relevant documents related to regulatory activities, and ensuring that Global SOPs and guidance are adopted in local SOPs.
- Participate in Issue Management Teams (IMTs) and recall management activities as a back-up of the Local Recall Administrator.
Manage communications with Regulatory Authorities following actions determined by the central Issue Management Team, which may include market action.
Scope includes all products distributed within Italy.
- Review promotional materials from a regulatory perspective to ensure compliance with local legislation and MC Code/SOPs.
- Actively participate in business product teams and local/international meetings.
- Estimate the Time to Market (TTM) for AZ products and competitors.
- Support Market Access and Marketing for P&R dossier.
- Manage special projects like MA transfer with the support of the Line Manager, if necessary.
- Manage other regulatory associates for the above-mentioned activities.
Essential Skills/Experience - University Degree in Science or related discipline - Good knowledge of National and EU pharmaceutical legislation - Experience in an area of regulatory affairs - Experience of working on cross-functional teams Desirable Skills/Experience - Master's degree or equivalent in science/healthcare related field - Prior pharmaceutical industry experience - Experience at a healthcare authority At AstraZeneca, we are at the forefront of shaping the future of healthcare.
Our unique position as medical leaders allows us to drive meaningful change through partnerships with external experts, policy makers, and patient groups.
We thrive on innovation and collaboration, working across different markets and functions to deliver science to patients in need.
Our dynamic environment offers endless opportunities for growth and development, making a significant impact on patients' lives.
Join us in making a difference - apply today! Date Posted 06-lis- Closing Date 20-lis- AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Somos una compañía biofarmacéutica global e innovadora.
En AstraZeneca nos enfocamos en el potencial de la ciencia para hacer frente a las necesidades no cubiertas de los pacientes en todo el mundo.
Nos comprometemos en aquellas áreas en las que creemos que realmente podemos cambiar el curso de la medicina y hacer realidad nuevas grandes ideas.
Somos un lugar donde la libertad de pensamiento y la creatividad alimentan nuestra determinación por marcar la diferencia a través de la ciencia.
Nuestra ciencia vive más allá de nuestros laboratorios.
Nuestra perspectiva global significa que utilizamos el talento y la experiencia de todo el mundo para hacer que nuestros medicamentos sean exitosos.
En AstraZeneca el único que puede poner límites al alcance de su carrera eres tú.
Con los conocimientos adecuados y la pasión te ayudaremos a explorar lo que AstraZeneca puede ofrecerte.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you.
to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.