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Regulatory Compliance Officer
Il y a 2 mois
About the Role:
Consultys is seeking a highly skilled Regulatory Affairs Specialist to join our team in Normandy. As a key member of our regulatory team, you will be responsible for preparing and submitting technical dossiers to regulatory authorities, including CTD dossiers, variation dossiers, and renewal dossiers.
Key Responsibilities:
- Prepare and submit technical dossiers to regulatory authorities, including CTD dossiers, variation dossiers, and renewal dossiers.
- Manage responses to regulatory authority questions and participate in audits.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Stay up-to-date with regulatory requirements and changes.
Requirements:
- Master's degree in a relevant field (e.g., engineering, pharmaceutical sciences) and 2+ years of experience in regulatory affairs in the pharmaceutical industry.
- Strong knowledge of regulatory frameworks, including GMP, BPF, and CE.
- Excellent written and verbal communication skills in English (TOEIC > 700).
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Strong analytical and problem-solving skills.
About Consultys:
Consultys is a dynamic and innovative company that values individual performance and teamwork. We offer a collaborative and supportive work environment, opportunities for professional growth, and a competitive compensation package.
