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International CMC Regulatory Affairs Lead
2 months ago
Position Overview:
Are you interested in becoming part of a global organization that values your contributions and offers exceptional career growth in a collaborative environment? In this role, you will take on CMC responsibilities for one of our established products and contribute to various development initiatives.
As a member of our Small Molecule team, you will oversee all global regulatory CMC activities throughout the development phase, registration for international market expansions, and lifecycle management for small molecules and peptide products.
About Ferring:
We are seeking a dedicated Global Regulatory Affairs Manager to join our regulatory CMC department. This position involves managing lifecycle projects for one of our well-established products.
Your Role at Ferring:
In your capacity as a Global Regulatory Affairs Manager within the CMC department, you will collaborate with various stakeholders, including manufacturing sites, quality assurance, and supply chain teams, as well as colleagues in global regulatory affairs. Reporting to the Director, your key responsibilities will include:
- Overseeing the CMC components of regulatory submissions and approvals for global market expansions.
- Providing regulatory CMC strategies and insights to cross-functional teams, including Global Regulatory Project Teams, CMC Teams, Product Teams, and Launch Teams.
- Conducting regulatory impact assessments of CMC changes for development projects and established products, ensuring timely documentation generation, submission, and approval worldwide.
- Leading and executing Scientific Advice sessions with national Competent Authorities concerning CMC activities.
- Actively participating in the development and enhancement of departmental processes.
What We Seek:
To thrive in this role, we believe you should possess:
- A minimum of 5 years of experience in global regulatory affairs, preferably in regulatory CMC.
- A Master’s degree in life sciences or pharmacy.
- Experience in facilitating risk management discussions is advantageous.
- A proactive approach to finding innovative solutions to regulatory challenges.
- Strong organizational skills with the ability to plan, execute, and meet deadlines.
- A collaborative mindset and excellent negotiation skills, with the capacity to navigate ambiguity.
- Proficiency in IT tools, including MS Office.
Our Commitment:
The Global Regulatory Affairs CMC department consists of approximately 30 professionals, including regulatory product/project managers and medical device managers, all working collaboratively. You will be part of the Small Molecule team, responsible for small molecules and peptides. Our department is dedicated to managing all global regulatory CMC activities during development, registration, and approval, as well as lifecycle activities for products and medical devices.
At Ferring, we prioritize our people, ensuring that both our patients and employees are at the heart of our operations. We are committed to supporting each other in achieving excellence and fostering career development for all team members.
Join Us:
If our mission resonates with your professional aspirations, we encourage you to consider this opportunity. Please include a brief statement about your motivation for applying in your CV or cover letter. Note that we review applications continuously and will close the process once we find the right candidate.
