Regulatory Compliance Expert
2 weeks ago
Position Overview
We are seeking a skilled Regulatory Compliance Expert to join our team. This role involves supporting international drug product applications and ensuring adherence to regulatory standards.
About Curium Pharma
Curium Pharma is a leading company in the nuclear medicine sector, dedicated to developing, manufacturing, and distributing innovative radiopharmaceutical products that enhance patient care globally. Our commitment to excellence and innovation drives us to deliver high-quality solutions for life-threatening diseases.
Key Responsibilities
- Author and compile drug product dossiers in CTD format for international market expansion.
- Manage variations for marketed products outside the United States.
- Respond to inquiries from health authorities to facilitate product approvals.
- Evaluate CMC regulatory impacts and develop strategies for post-approval changes.
- Collaborate with cross-functional teams to support initial international filings and subsequent modifications.
- Assist in creating foreign language labeling content to comply with local health authority requirements.
- Maintain up-to-date knowledge of regulatory guidelines and standards.
- Oversee regulatory databases and generate necessary reports.
- Provide mentorship to junior regulatory associates.
Essential Qualifications
- Bachelor's degree in a scientific discipline or equivalent experience.
- A minimum of three years of experience in regulatory affairs or a related field.
- Proactive self-starter with a desire to excel in the regulatory profession.
- Experience in manufacturing, research and development, or quality assurance.
- Strong organizational skills and attention to detail.
- Excellent problem-solving abilities and teamwork skills.
- Proficient in Microsoft Office and Adobe Acrobat.
Working Conditions
This position is based in a standard office environment, requiring the ability to work collaboratively in a team-oriented setting. Candidates should be prepared for occasional travel and flexible working hours.
Equal Opportunity Statement
Curium Pharma is an equal opportunity employer, committed to fostering a diverse and inclusive workplace. We welcome applications from all qualified individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
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