Manager, Orsse Labeling

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

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 labeling-related 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
- Multi-cultural 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

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