Associate Director, Regulatory Affairs
vor 3 Wochen
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology, and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and well-being.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
About the role
As Senior Manager / Associate Director – Global Regulatory Lead (GRL), you will be accountable for the global regulatory strategy for assigned product(s).
Core responsibilities:
• Develop and execute a global regulatory strategy
• Represent regulatory on inhouse development teams and drive regulatory discussion topics
• Develop registration strategies and plans aimed at achieving regulatory approval with optimized product labeling
• Provide regulatory expertise to new product developments (primarily 505b2/hybrid)
• Lead the correspondence with regulators, meeting requests, inhouse preparation and regulatory interactions where relevant
• Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to the product/projects, submission targets and proactively communicates them to implement necessary adjustments to strategies or content
• Selection and management of vendors providing regulatory services
Role Requirements:
• Relevant scientific degree
• Significant experience in regulatory affairs (+ 7 years)
• Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
• Demonstrated ability to break down complex, scientific issues and communicate regulatory implications
• Strong knowledge of US and European regulations applicable to drug development and registrations, in particular to inhalation products
• Proven success in negotiating regulatory objectives with health authorities
• Experience in leading preparation for meetings and communications with regulators, specifically in the US and EU/UK
• Experience from 505b2/hybrid developments an advantage
• Experience from inhalation products an advantage
• Experience working in matrix teams
• Comfortable working in a fast-paced, launch-oriented environment
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunities to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
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