
Senior Regulatory Compliance Officer
1 week ago
We are seeking an experienced Regulatory Affairs Specialist to join our operations as we expand globally.
Key Responsibilities:- Prepare high-quality dossiers for marketing authorisation applications, responses to health authority questions, and post-approval submissions.
- Submit applications to regulatory authorities.
- Review data intended for submission and advise on any deficiencies or issues.
- Ensure timely submissions for quality/safety related changes for assigned projects.
- Prepare translated texts for international markets.
- Update databases and systems for all products according to current SOPs.
- Establish effective communication with stakeholders to progress regulatory activities.
- Masters/Bachelor's degree in Science/Technology/Pharmacy.
- Minimum 5 years of experience in Regulatory.
- Strong understanding of health authority expectations for pharmaceuticals in EU/US regions.
- Excellent organisational, time management, and attention to detail skills.
- Critical thinking and problem-solving abilities.
- Strong interpersonal and communication skills.
- Experience in dealing with multiple stakeholders.
- Collaboration and customer satisfaction.
- Creating a workplace culture that encourages creativity, open communication, and mutual respect.
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