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
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