Regulatory Affairs Associate till konsultuppdrag

Experis Engineering söker en ingenjör inom läkemedel eller kemi till AstraZeneca för ett konsultuppdrag som Regulatory Affairs Associate. Uppdraget är 12 månader med möjlighet till förlängning.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.

The Arena

AstraZeneca has decided to divest some of the products that are currently in our portfolio to enable resources and support the strategy of launch of new products in line with our core therapeutic areas. The Regulatory Affairs Associate will work in close cooperation with the Regulatory Affairs Managers and with other functions within our Nordic-Baltic Marketing Company, to support efficient management of divestment projects. In addition, he/she will support with efficient and timely regulatory processes for successful launches and lifecycle management of products in the AZ portfolio. He/she will provide regulatory input to support across the organization to ensure that our products meet all regulatory requirements and with the focus on patients access to safe medicines.



Description

The assignment is to work with regulatory activities for divestment projects, but also to support the Regulatory department with different type of submission related activities for our products. This means that:

* You coordinate projects, prepare documents and submissions to Health Authorities in connection to divestment projects.
* You work flexibly within the Regulatory Team and support and contribute with regulatory activities and insights, including support and guidance to cross-functional teams.
* You work with preparation of labelling documents for artwork for products on market
* You work in a structured way assuring all steps for a task are performed in a timely manner.
* You understand and comply with the ways of working and strive for improving those.
* You identify opportunities as well as show stoppers in business related or compliance related areas.
* You master the electronic tools and functionalities in the Regulatory function, and you make it easy for others to operate by keeping the structure and good order.



Typical accountabilities and responsibilities

* Responsible for preparation of regulatory submissions to support divestment projects and supporting high quality submissions and fast approvals
* Communicates with authorities on pending issues and requirements; drives and develops key AZ specific regulatory questions and processes
* Continuously updates stakeholders and TA teams on regulatory requirements and timelines for completing / managing regulatory activities in connection to divestment projects
* Ensures that product information, labelling, artwork and other materials meet external requirements and AZ policies
* Works in close cooperation with European and global regulatory colleagues
* Contributes to the development of an effective team
* Ensures personal competence development
* Contributes to the overall development of the department and positive attitude towards working and developing
* Actively contributes to continuous improvements within the function
* Assures tasks are of correct quality and in accordance with written procedures and current legal requirements and internal standards



Education and Experience, essential

* Bachelor's degree or Master's degree in Pharmacy, Chemistry, Biology or equivalent
* Demonstrated experience with Regulatory work by working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or at a health authority
* Excellent written and verbal communication skills
* Excellent knowledge of English and at least one of the Nordic languages
* Good knowledge of relevant legislation requirements and procedures
* Strong ability to work collaboratively



Desirable

* Experience from pharmaceutical development, manufacturing or quality assurance
* Experience from health authority work
* Solid business acumen and a good RA toolbox to apply
* Good at influencing and building relationships with senior stakeholders
* Ability to plan, communicate and drive processes and projects all the way to the finish line



Key relationships to reach solution

Internal

* Global Regulatory Affairs teams
* European Regulatory Affairs
* Regulatory CMC teams
* TA teams/Business Units
* Medical function
* Logistic function
* Marketing and Market Access
* Production sites



External

* Labelling and translation CRO
* National Health Authorities
* Local / National trade associations and working groups



Application

Apply for this position with a registered or attached resume at www.experis.se. The selection will be ongoing so apply therefore as soon as possible!