Job title:Regulatory affairs manager 1(astra zeneca)

Key Responsibilities:

• Regulatory Affairs Management: Understand regional regulatory frameworks, deliver submission strategies, review documents, and contribute to regulatory maintenance submissions.

• Global Labelling Management: Maintain core labeling documents, ensure compliance with regional regulations, and manage labeling updates.

• Dossier Management: Coordinate dossier management deliverables, manage publishing tasks, and address regulatory risks.

Essential Skills:

• University degree in Science or related field.

• At least 6 years of regulatory experience within biopharmaceuticals, including license maintenance, labeling, and publishing.

• Strong project management, leadership, and communication skills.

Desirable Skills:

• Experience in regulatory affairs across various global markets, particularly Europe and the USA.