This is a rare opportunity to join one of the most exciting young global biopharmaceutical companies, headquartered here in Dublin. With a rich development and commercial pipeline, our client is focussed on rare and orphan diseases.
The Regulatory Affairs Manager, International, provides regulatory expertise to determine regulatory submission strategy and support to execute these strategies to ensure regulatory approvals and compliance in international markets. International markets to include South America
- Work with members of the Global Regulatory Affairs team to determine and implement international regulatory strategies through the preparation of submission dossiers for registration of new products and changes to existing products.
- Liaise with regional regulatory counterparts/distributors to ensure regional requirements are incorporated and met in support of regional new product registrations/new submissions.
- Coordinate with regional counterparts/distributors and regulatory operations to ensure timely and accurate submissions to Regulatory Authorities.
- Act as a regulatory contact with internal commercial and medical affairs teams to understand and support business needs and coordinate internally international regulatory communications, submissions and registrations.
- Ensure timely registration to meet preferred launch timeframes in compliance with applicable regulations and guidance.
- Provide regulatory support for product launches.
- Support International documentation needs including Certificate of Pharmaceutical Products
- Implement and manage compliant processes to collect and maintain regulatory authority product registrations, approvals and communications
- Act as the regulatory liaison with third-party distributors and regulatory agencies to address questions and issues that may arise during the registration process.
- Maintain up-to-date knowledge of relevant international regulations and provide this expertise proactively to cross-functional teams.
- Bachelor’s degree in science or health-related field.
- 5+ years relevant pharmaceutical industry and regulatory experience.
- International regulatory affairs experience highly preferred
- Knowledge of pharmaceutical regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Labelling, CMC, Quality and Operations
- Ability to interpret Regulatory Authority policies and guidance globally and liaise internally and externally to ensure they are correctly applied in regulatory activities.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
- Ability to communicate effectively across different cultures and countries.
- Ability to influence and partner with cross-functional teams in a global pharmaceutical organisation.
- Ability to manage multiple priorities in support of multiple concurrent agency registration or submissions and questions.
- Prior experience managing projects is preferred.
- Excellent communication skills; both oral and written.
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