Professional | Permanent | Full-time | Hybrid
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
* Plan, prepare, revise and maintain the regulatory CMC documentation for the assigned products;
* Proactively develop, in cooperation with internal and external stakeholders, the global CMC strategies for the registration and maintenance of active substances and finished products;
* Provide advice to Grünenthal manufacturing sites, suppliers and customers/partners regarding CMC regulatory requirements considering national and international regulatory standards;
* Provide CMC assessment and strategic input for proposed product changes, identifying risks, proposing mitigations as well as highlighting opportunities to maximize chances of success for regulatory approvals;
* Partner closely with Quality, Regulatory Affairs, Supply Chain, Commercial, and external manufacturing partners to align on product and process changes.
What You’ll Bring To The Table
* Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, or related scientific degree;
* + 5 years experience in the pharmaceutical industry, with at least 2 years in a CMC role;
* Strong background in CMC lifecycle management and post-approval change implementation;
* Deep understanding of small molecule manufacturing, control strategies, and regulatory compliance;
* Strong knowledge of global CMC regulatory requirements (ICH guidelines, GMP regulations and regulatory frameworks worldwide);
* Excellent organizational, management, and skills;
* Proactive decision-maker with the ability to balance risk, compliance, and business needs;
* Proven ability manage complex product portfolios;
* Capability to manage multiple tasks and prioritize in a regulated environment;
* Very good written and verbal communication skills in English;
* Good knowledge in verbal and written Spanish;
* Proficiency in Excel, Word, and digital documentation tools.
Contact
Ana Lúcia Vasconcelos, the Hiring Manager
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