The Regulatory Affairs Manager will lead, manage, and provide strategic direction and oversight to the Head of regulatory affairs and above regulatory teams to develop and execute regulatory strategies and plans for the country.
Job responsibilities:

• Manage the assigned portfolio in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.
• Develop strong partnerships with in-country (e.g. BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, Therapeutic Area and Regional Teams) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Responsible for their own personal development, leadership and performance to achieve company objectives and agree training and development needs with Country Regulatory Heads to develop and enhance individual capabilities and capacities.
• Responsible for developing and enhancing relationships with key external agencies (HAs/BoH, Regulatory KOLs, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOPs and systems are followed ensuring training in P2L are completed 100% (systems and procedures).
• Maintain compliance at 100% in all regulatory systems.Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established EM performance metrics.

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