Senior Global Regulatory Project Lead for Uro/Uro-Oncology
In this role, you will be responsible for our gene therapy projects' regulatory activities and strategies focused on treating severe cancer diseases.
We are looking for you to apply your extensive regulatory knowledge as you collaborate with health authorities and other pharmaceutical companies to set the stage for us to succeed in getting our product into new markets. In return, we offer you the freedom to impact our working methods and expand your personal toolkit.
Ferring + You
You will become integral to our Global Regulatory Affairs, Uro/Uro-Oncology team. We support all global development projects and life cycle management of marketed products within the Uro/Uro-Oncology portfolio. Additionally, we are responsible for developing and executing our global regulatory strategies, including worldwide submission planning, market expansions, product expansions and updates.
Overall, you can look forward to cross-functional collaboration with colleagues across the global functions and colleagues in our regional and affiliate offices.
Your day at Ferring
As a senior global regulatory lead, you will be responsible for our gene therapy project's regulatory activities and strategies focused on treating severe cancer diseases. As our gene therapy portfolio is expanding, you will work across functions with colleagues within GRA to ensure that we have the right regulatory strategies and marketing approval worldwide, and you will be involved in the development projects.
Contributing to the continuous improvement of the department and GRA working processes, you will:
- Act as a member of our Global Project Team and chair of the Global Regulatory Teams for the gene therapy projects in the development portfolio, providing regulatory strategic expert input;
- Drive the development of high-quality global regulatory strategies, including the identification of regulatory opportunities and mitigation of risks, strategic submission and regulatory activity planning, and development of competitive labels in collaboration with relevant team members and stakeholders;
- Plan and manage meetings with health authorities worldwide for assigned projects – and drive and lead the preparation of high-quality briefing packages, liaising with health authorities and experts to obtain crucial scientific advice to mitigate project regulatory risks and enable project progression;
- Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the product development phases – and provide input to clinical and nonclinical documentation and represent GRA in our Clinical Development and Safety Management teams;
- For late-stage projects, ensure submission and approvals of BLAs/MAAs in US, EU, Japan, China and other countries worldwide in collaboration with local regulatory colleagues, and drive the strategic planning of all market expansions including responses to authority inquiries;
- Represent regulatory in project presentations and discussions with upper management and governance bodies at project milestones;
- Provide input to external evaluation of business opportunities.
Behind our innovation – there’s you
We are looking for someone with a proactive and highly strategic mindset. You have the experience and the ability to plan and execute regulatory submissions, and you are equally confident and comfortable representing Regulatory Affairs in project presentations for senior management and discussions with Ferring governance bodies.
You bring strong negotiation skills, solid judgement and effective decision-making abilities – and you know when to push forward and when to hold back. You are a true team player with a positive mindset and a constructive attitude towards driving results, and you are keen on working in an international corporate environment with a diverse and flexible workday.
Previous experience with regulatory requirements for cancer and/or gene therapy products is an advantage, and in addition:
- You have a university degree in science;
- You have 12+ years of comprehensive experience with drug development from phase 1 to launch;
- You have experience managing global regulatory activities and driving regulatory strategic project discussions;
- You have experience engaging with health authorities (FDA, EMA, Japan and China);
- You have experience with labelling, clinical trials and other clinical and non-clinical regulatory activities;
- You have excellent verbal and written communication skills in English.
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