Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. Thats why we are always looking for curious minds that see themselves imagining the unimageable with us.
Your Role:
• The Specialist Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements.
• Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.
• Will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs.
• You will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel.
Who You Are:
• Minimum 5 years of overall work experience in Pharma workplace, Competent authority or Academia/R&D; experience related to the role. Minimum 1 year of Regulatory affairs experience
• Degree in a Life Science or a related discipline, preferably MSc
• Experience in preparation and management of regulatory documentation, normally a full international submission (current product application) or large variations.
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset).
• Positive knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally.
• Understanding of supportive documents necessary for the registration and LCM
📌 Specialist Regulatory Affairs Manager Bengaluru (India)
🏢 The businesses of Merck KGaA, Darmstadt, Germany
📍 India
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