Regulatory Affairs Professional for EU Compliance
6 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance with EU regulations. This role is pivotal in managing activities related to new application submissions through DCP, MRP, NP.
This position requires excellent communication skills, both written and verbal, to effectively interact with EU regulatory authorities and internal stakeholders.
- Prepare, review, and submit new applications through DCP, MRP, NP for EU.
- Develop and review m1 documentation in-line with m2-5 documents.
- Create product information and review artworks to ensure regulatory compliance.
To be successful in this role, you will need:
- A Master's degree in a relevant field (M.Sc or M.Pharm).
- A minimum of 8 to 12 years of experience in regulatory affairs, preferably in Europe registrations.
- Knowledge of EMA guidelines and proficiency in spoken and written English.
- Excellent interpersonal and communication skills, with attention to detail and ability to multi-task.
This role offers a unique opportunity to work in a dynamic environment, where you will have the chance to develop your skills and expertise in regulatory affairs. You will be part of a dedicated team that values collaboration and innovation.
OthersPlease note that this role requires a high level of discretion and confidentiality. If you are a motivated and organized individual with a passion for regulatory affairs, we encourage you to apply.
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