Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
About the role
- Senior Consultant in Regulatory Affairs consulting at QbD Group. Leading regulatory projects for life sciences companies with a global success story.
Responsibilities
- You provide a full range of high-quality regulatory consulting services (strategy and writing).
- You manage complex regulatory projects with multiple stakeholders.
- You act as strategic lead overseeing project scope, timelines, and budgets.
- You lead and coordinate activities within multidisciplinary teams .
- You delegate tasks and supervise the work of team members.
- You are a trusted regulatory expert across product development and life-cycle activities.
- You interact professionally and effectively with senior management and client leadership.
- You build and maintain a strong network of client, industry, and regulatory relationships to build confidence in and enhance the reputation of QbD Group.
- You support business development and proposal preparation .
- You have significant regulatory affairs experience including a successful track record in the development and/or registration and/or life-cycle maintenance of medicinal products.
Requirements
- You have a university degree in life science .
- You have sound knowledge of European/UK/US pharmaceutical regulations and guidelines .
- You have significant regulatory affairs experience including a successful track record in the development, registration and life-cycle maintenance of medicinal products.
- You have excellent written and verbal communication skills and proven negotiation skills . You can establish strong connections with clients, regulators, management and colleagues.
- You have good organizational skills and an analytical mindset.
- You enjoy working in an international environment .
- A true QbD’er can be recognized by the following qualities:
- o Resilient : Your strong and positive attitude helps you overcome any challenge
- o Hungry for knowledge: You are always open to learning
- o No non-sense mentality: you can be straightforward in a respectful way
- o Innovative : You are constantly looking for new and better solutions
- o (Not too) serious : your job is serious, but you don’t take yourself too serious
Benefits
- QbD Group offers you an attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations.
- Join us to build a sustainable career , where job security is ensured, and lasting, meaningful connections are formed.
- As we’re a knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development.
- Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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