Support Regulatory Affairs
WHAT ARE YOUR RESPONSIBILITIES?
- Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
- Liaising with Regional Submission Planner (accountable for planning in Regulatory Operations) to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines of Module 1 components.
- Drafting and organizing the gathering of the module 1 components.
- Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies.
- Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling.
- For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA.
- Ensuring updates to regulatory databases.
- Keep up to date with EU procedural requirements and legislation.
WHO ARE WE LOOKING FOR?
- Degree in life sciences. Minimum of 2 years experience in the pharmaceutical industry. Knowledge of EU regulatory procedures and development of medicinal products in general is preferred. Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
- Can work across boundaries: demonstrates the ability to act as intermediary across boundaries.
- Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
- Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.
- Demonstrates the ability to review regulatory documents for accuracy.
- Understands the end-to-end pharmaceutical lifecycle.
- Considers the recent innovations when formulating recommendations.
- Evaluates activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation.
WHAT DOES QBD OFFER YOU?
- A young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- Personal and professional development through guidance, education and knowledge sharing
- A competence development model focused on your personal ambitions
- An attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.
Interested? Apply now by sending us your CV and motivation.