Manager, Regulatory Affairs - Barcelona, España - G&L Healthcare Advisors

Descripción

• The preparation of CMC regulatory documents and/or other regulatory documents for MAA and Post Approval Lifecycle projects including renewals, variations, annual reports etc.
• Working with manufacturing sites on change control projects; providing regulatory advice and strategic guidance.
• Managing multiple projects simultaneously; providing data assessment and conclusions.
• Identifying risks associated with submission data and information packages and then proposing mitigation plans.
• Efficiently interacting with customers and senior stakeholders as required.
• Identifying improvement opportunities for Regulatory processes, policies and systems.
• Contributing to process improvement and regulatory intelligence projects.

• 48 years of working experience in Regulatory Affairs.
• Previous experience working for a consultancy company would be a benefit.
• Small and large molecule experience, ideally across multiple therapy areas/dosage forms
• Impeccable communication skills and flexible approach; diplomacy and negotiating skills.

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.