CMC Compliance Product Manager

Description

Summary: This role involves planning, preparing, revising, and maintaining regulatory CMC documentation, proactively developing global CMC strategies, and providing expert advice on regulatory requirements. Highlights: 1. Lead CMC strategy for active substances and finished products 2. Advise on CMC regulatory requirements for manufacturing sites and partners 3. Partner with diverse teams for product and process changes share mail share share CMC Compliance Product Manager **Country:** Portugal **City:** Lisbon **Department:** Global Operations \& Production **Job ID:** 45249 **Job Grade:** PT12F **Hiring Manager:** Ana Lúcia Vasconcelos **Internal Posting Date:** \- **Referral Bonus:** 500\.00 EUR 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 assignedproducts; * Proactively develop, in cooperation with internal and external stakeholders, the globalCMC strategies for the registration and maintenance of active substances and finishedproducts; * Provide advice to Grünenthal manufacturing sites, suppliers and customers/partnersregarding CMC regulatory requirements considering national and internationalregulatory standards; * Provide CMC assessment and strategic input for proposed product changes, identifyingrisks, proposing mitigations as well as highlighting opportunities to maximize chances ofsuccess for regulatory approvals; * Partner closely with Quality, Regulatory Affairs, Supply Chain, Commercial, andexternal 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; * Proficiency in Excel, Word, and digital documentation tools. **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** Ana Lúcia Vasconcelos, the Hiring Manager About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science\-based, privately\-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state\-of\-the\-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1\.8 billion. Your HR contact: Sara Marques