Associate Director Regulatory Affairs Lifecycle Management

We have an exciting opportunity for an Associate Director Medical Devices Lifecycle Management to join Norgine. The person holding this position will report to the Director Regulatory Lifecycle Management and be a member of the Regulatory team. The Associate Director Regulatory Affairs is responsible for the regulatory leadership of their global life-cycle management product portfolio across Norgine functions, the Outsourced Service Provider and vis-à-vis the Health Authorities. This encompasses leadership of regulatory integration of new products following license approval or acquisition of approved licenses and all associated following regulatory maintenance activities. The Associate Director Regulatory Affairs will lead the global regulatory portfolio with autonomy to successfully deliver against strategic and operational plans delivered in partnership with the Development Outsourced Service Provider(s).,

• Drives effective delivery of global regulatory strategies for registered medicines ensuring that regulatory plans are prioritised, optimised and risks are mitigated
• Develops and executes strategies to ensure regulatory submissions are delivered with integrity, compliance with legislative standards and harmonised across the licence portfolio in cooperation with the Regulatory Affairs Lifecycle team.
• Leads strong regulatory partnerships with Development departments, Business Units, Commercial, Quality and Manufacturing and Supply to understand business requirements and create aligned strategic solutions
• Leads the operational regulatory work of the Outsourced Service Provider staff to ensure effective and successful execution of regulatory submissions and oversight of procedures.
• Acts as key Norgine representative at inspections and audits and takes over leadership for assigned products/ procedures in relation to regulatory compliance
• Oversees and supervises regulatory objectives and the quality and content of submission documentation delivered by the Development Outsourced Service provider(s)
• Keeps on top of current regulations and guidance, interprets complex requirements, produces and executes against clear strategies and communicates to global personnel
• Proactively works within cross-functional teams and takes over leadership for RA to integrate new products into Norgine GDO organisation and systems
• Provides proactive guidance to internal groups based on product and regulatory knowledge. Identifies and assesses risks associated with the data available and approach to achieve desired outcomes for assigned projects
• Provides guidance and advice to the business when developing and presenting regulatory strategy, ensuring that regulatory plans are optimised and risks are mitigated
• Provides regulatory leadership at brand team and project team meetings
• Leads close communication with senior cross-functional stakeholders to understand impact of planned regulatory changes, both financially and operationally and provide advice on regulatory submission strategies to Outsourced Service Provider
• Proactively leads communication with key internal stakeholders and the Regulatory Authorities to deliver against objectives set by the business
• Ensures via Outsourced Service Provider that submissions are made are of high quality, in compliance with regulatory requirements, submitted and approved timely in accordance with business need
• Delivers portfolio figures into the budgeting process e.g. relating to regulatory fees and CRO support required for prospective regulatory submissions
• Ensures adherence to compliance policies
• Actively participates in industry forums to represent Norgine and shape future ways of working, providing leadership and insight within Norgine through engagement with regulators, service providers and industry professionals who influence best practice
• Actively trains/mentors staff; provides broader guidance on continuous improvement of published guidance and legislation
• Aspires to continuously develop technical/professional knowledge and interpersonal/management expertise to be a good role model, Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.
  
  Minimum BSc and MSc or PhD or PharmD or M.D. in science or healthcare preferred or equivalent relevant experience
• Must have proven Regulatory Affairs management experience at a senior level. The regulatory experience must be broad across therapeutic areas and application types to ensure autonomous leadership
• Proven ability to effectively communicate with the regulatory authorities
• Proven experience of managing relationships with outsourced service providers to deliver regulatory activities
  
  At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community. In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do. Because at Norgine, we transform lives with innovative healthcare solutions.