Submission & Lifecycle Manager, AstraZeneca Gothenburg

Job description
Do you have pharmaceutical experience within regulatory as well as a knowledge of labeling regulations and guidelines? Then AstraZeneca might be of interest to you!  We are now looking for a Submission & Lifecycle Manager to the Global Labeling team at AstraZeneca in Gothenburg.

The Global Labeling Delivery Manager is responsible for document management of EU and US labeling for assigned marketed and/or pipeline products. This includes delivering high-quality, submission ready documents according to required timelines, managing the EU linguistic review process and authoring content of labeling for US SPL submissions. This is a consulting assignment at AstraZeneca in Gothenburg.

Responsibilities
Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Provide support to Global 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 Global Labeling Strategy and RPM 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. 


Qualifications
Minimum requirements: 
University Degree in Science or related discipline
1 to 5 years 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 (works well across formal and informal networks) 
Negotiation Skills (good listener; able to build a consensus)
Critical Information Seeking (works well across formal and informal networks)
Rational Persuasion (able to distil an issue to its key components and suggest solutions)
Interpersonal Awareness (aware of how actions affect other people)


Preferred Background:
Experience in packaging labeling development and/or maintenance

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-03-10, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information, please contact Linnea Öster linnea.oster@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!