Country: Portugal
City: Lisbon
Department: Global Operations & Production
Job ID: 44336
Full-time
Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you're a dynamic person with a positive mindset, you'll fit in well here. It's an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal's future.
What the job looks like:
Planning, defining, compiling, revising, and maintaining the regulatory CMC quality section for the supervised product portfolio worldwide;
Providing critical assessment and strategic input, flagging risks, proposing mitigations as well as highlighting opportunities for Grünenthal for the quality part of dossiers to maximize chances of success for approval;
Proactively developing, in cooperation with internal and external stakeholders, the global regulatory CMC strategies for active substances and finished products;
Ensuring Regulatory Compliance of the supervised product portfolio including but not limited to management of Product Change Control and review of GMP Master documentation;
Providing advice to Grünenthal manufacturing sites, suppliers, and customers/partners regarding CMC regulatory requirements considering national and international regulatory standards;
Support in transfers and in preparation of Technical Agreements with manufacturing site, affiliates, and suppliers in order to assure regulatory compliance;
Compilation of Product Quality Review Annex 5B;
Supporting due diligence and partnering activities as assigned;
Take-over of project-oriented special tasks;
What you'll bring to the table:
Degree as a Pharmacist or as another natural scientist;
Profound experience in regulatory CMC for NCEs, knowledge of Medical devices (Drug product combinations) is beneficial;
Proven track record in QA and/or GMP environment and in-depth knowledge of relevant national and international guidelines and regulatory requirements for e.g. US, EU, Japan, and rest of the world (RoW);
Experience in critically reviewing detailed scientific information to ensure information is thoroughly assessed, presented clearly, and supported by data;
Demonstrate ability to build and maintain influential relationships with internal and external stakeholders to convey and exchange information;
Decision making also in challenging situations;
Strong oral and written communication skills, especially in English; another language would be a plus, preferably German.
Alexandra Scheier, the Hiring Manager
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