Head CMC Compliance Internal Manufacturing Latam

Our Corporate Functions teams make sure everything at Grünenthal runs smoothly by bringing together people with a wide range of skills – from experts in finance, IT, HR, law and compliance through to business strategists and creative media minds. If you’re a great collaborator and a strong communicator, you’ll feel right at home here. Join our team and join forces with colleagues across our business to maximise our company’s positive impact on patients and their families.

What the job looks like:

• Accountable for developing, coaching and supervising team members;
• Designing regulatory CMC strategy in cooperation with stakeholders and aligned with overall project plan if applicable;
• Conception of planning and interdepartmental coordination for gaining as well as maintaining MAs for CMC topics in time and quality including CMC work packages;
• Responsible for execution for medicinal products supervised designing CMC strategies and providing guidance to ensure regulatory compliance in time and quality;
• Set up, review and establish appropriate efficient (global) processes for management of lifecycle product portfolio in cooperation with stakeholders based on functional expertise, benchmarking, innovation and lean principles;
• Support of GQA CMC projects to execute according to current standards and in time and quality to ensure safe and reliable products for our patients;
• Operational Responsibilities;
• Accountable for setting up and coordinating appropriate and timely preparation, review and maintenance of CMC sections of CMC dossiers in line with plan;
• Providing guidance for operational CMC regulatory support with overall responsibility for the regulatory compliance of supervised product portfolio including management of changes;
• Accountable for the financial planning & adherence; manage the operative expenses.

What you'll bring to the table:

• Sound experience (5 years plus) in CMC Regulatory as well as in GMP environment;
• Preferably Pharmacist or other natural scientist degree;
• Leadership experience of (virtual teams), multi-country;
• Knowledge of relevant national and internal guidelines and regulatory requirements for eg. EU, US, LatAm, JPN;
• Very good verbal and written English. Spanish language skills advantageous;
• Strong communication and negotiation attitudes; able to influence the stakeholders and external parties, driving cultural, organizational and process changes;
• Global and service-oriented mind-set, strong sense of cultural/diverse backgrounds and very good relationship management skills;
• Capable working under tight and shifting conditions.

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