Manager, Orsse Labeling - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Are you ready to take on a role that prepares and executes global/regional regulatory tactical submission plans on allocated projects/products? This role is designed for individuals who are ready to implement the agreed regulatory strategy to develop and maintain products.

As a Manager, ORSSE Labeling, you will generate and project manage the delivery of submissions, ensuring they meet time and quality standards.

This role is perfect for those who have in-depth knowledge of Regulatory compliances and submissions, and are ready to build good relationships with internal customers and Regulatory authorities.

Accountabilities:

Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Provide support to the Labeling Strategist with regards to labeling documents for submission
Provide guidance to labeling teams regarding regulatory technical requirements for regional labeling submissions
Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission documents
Understand industry labeling trends related to labeling and submission guidance and directives
Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate
Liase with Labeling Strategy and RAM to advise/recommend submission best practices
Contribute the regulatory labeling perspective in support of submission delivery
At the request of Labeling Strategist, originate precedent searches, create and maintain labeling comparisons
Interact with Marketing Company colleagues regarding linguistic review and translations
Oversee and coordinate EU linguistic review process as appropriate
Interact with appropriate functional groups to obtain labeling annotations and supporting documentation
Author Content of Labeling/Drug Listing SPL file
Generate and validate SPL file for submission
Draft summaries of relevant labeling changes for PSURs, Annual Reports and other periodic reports
Maintain labeling lifecycle of documents and ensure proper naming according to DNC
Coordinate with Regional Regulatory staff to deliver submission ready documents and ensure submission timelines are met
Assist in responding to labelingrelated queries from various functional areas
Assist Global Labeling team in resolution of labeling issues as needed
Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
Liaise with senior management as needed to resolve critical labeling issues
Represent functional expertise at relevant department meetings and relevant cross functional subteams

Essential Skills/Experience:

University Degree in Science or related discipline
1 to 3 or 3 to 5 years (depending on role) pharmaceutical experience, preferably regulatory experience, preferably working with labeling
Knowledge of labeling regulations and guidances
Keen attention to detail and accuracy
Excellent verbal and written communication skills
Multicultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Must demonstrate competencies in: Building Relationships, Negotiation Skills, Critical Information Seeking, Rational Persuasion, Interpersonal Awareness

Desirable Skills/Experience:

Experience in packaging labeling development and/or maintenance

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.

In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?
At AstraZeneca's Oncology R&D department, we bring hope and solutions to patients with unmet needs across the globe.

As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients.

We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We are all compassionate team players and driven achievers, always ready to step up. We're motivated by science, success and achieving our goals in a way that's novel and thoughtful.

Are you ready to turn our pipeline into reality to impact unmet patient needs? Our rich and robust pipeline provides the opportunity to work with a variety of ground-breaking medicines across diverse therapy areas and at all stages of the development process.

We work to b