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- 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, xlwpduy 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.
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