Senior Regulatory Affairs Specialist
We are seeking a skilled Senior Regulatory Affairs Specialist to spearhead all aspects of regulatory affairs, encompassing existing licensed products and those in development.
* Preparation and maintenance of high-quality dossiers;
* Submission of CPP/Manufacturing authorization requests;
* Review of data intended for submission and advising on deficiencies or issues;
* Ensuring timely submissions for quality/safety-related changes;
* Liaising with third parties and internal colleagues to advance regulatory activities.
The ideal candidate will possess a Master's/Bachelor's degree in Science/Technology/Pharmacy, minimum 7 years of experience in regulatory affairs, and exceptional critical thinking and problem-solving abilities. They must exhibit strong interpersonal and communication skills, as well as the ability to comprehend health authority expectations across EU/US/ROW regions.
In this pivotal role, you will be responsible for overseeing all facets of regulatory affairs, including ensuring compliance with relevant regulations and guidelines. You will work closely with cross-functional teams to ensure seamless collaboration and effective decision-making. Your expertise in regulatory affairs will enable us to navigate complex regulatory landscapes and maintain our market position.
Key Requirements:
* Advanced degree in Science/Technology/Pharmacy;
* Minimum 7 years of experience in regulatory affairs;
* Exceptional critical thinking and problem-solving abilities;
* Strong interpersonal and communication skills;
* Ability to understand health authority expectations.