Regulatory Affairs Lead
Eirgen is expanding its influence through a series of strategic partnerships and innovations, driven by our dedication to delivering high-quality products. Our global presence spans multiple markets, with the United States, European Union, and Japan being key regions for growth.
The Regulatory Affairs Manager will be responsible for providing expert guidance on regulatory submissions, ensuring compliance with international regulations. This role will oversee all aspects of license maintenance, manage dossier preparation and submission processes, and develop long-term strategic plans for regulatory activities aligned with Eirgen's business goals in target markets.
This position requires strong leadership and problem-solving skills, as well as the ability to collaborate effectively with cross-functional teams. The ideal candidate will have a proven track record of managing regulatory submissions and compliance activities across multiple international markets.
* Key Responsibilities:
* Project planning and coordination: define regulatory requirements, allocate tasks and resources, and monitor progress to guarantee timely market entry.
* Regulatory compliance: oversee all aspects of license maintenance, act as primary liaison with Quality Assurance (QA), and anticipate compliance challenges.
* Licensing activities: manage and coordinate licensing activities for existing marketing authorizations across multiple global markets.
* Dossier preparation and submission management: lead the preparation and submission of regulatory dossiers for target markets, maintain communication with internal departments and external consultants.
Requirements:
* Minimum of a Bachelor's degree in Chemistry, Pharmacy, Pharmacology, or a related scientific discipline.
* At least 10 years of progressive experience in Regulatory Affairs, including significant responsibilities in supervisory or people management roles.
* A proven track record of successfully managing regulatory submissions and compliance activities across multiple international markets.
About You:
Eirgen offers a diverse, people-centric, high-performance culture where employees are enabled to achieve their potential. As a member of our team, you will have access to competitive salaries and an attractive range of benefits, including opportunities for career progression and continuing education.
This role will provide an opportunity to work in a dynamic environment, collaborate with cross-functional teams, and drive business growth through effective regulatory strategies.
Our Culture
At Eirgen, we prioritize creating a work environment that fosters collaboration, innovation, and continuous learning. Our culture emphasizes employee development, recognition, and engagement, with a focus on delivering high-quality results while maintaining the highest standards of compliance and quality.