Sr Manager, Regulatory Affairs

Description

• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional teams ( e.g., Study Management, Clinical, Nonclinical, Biomarkers and/or cross-regional Regulatory Submission Teams.
• With guidance, defines the regulatory strategy for one or more Gilead products or projects (development or marketed products).
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
• Leads the preparation, compilation, and timely filing of complex regulatory submissions, which require cross-functional interactions for commercial or investigational product(s) for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include meeting requests, briefing packages, initial clinical trial applications/Amendments or routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.) as well as post-approval submissions for marketed products.
• Leads cross-functional teams in the authoring of regulatory documents and including meeting requests.
• Responsible for ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
• Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Qualifications

• Life Science degree
• Extensive experience Regulatory Affairs or other relevant industry experience
• Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred.
• In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
• Good knowledge of regulatory requirements for the EU centralised procedure. Experience in co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
• Experience of regulatory requirements in other countries/regions is desirable.
• Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
• Experience in working with document management systems.
• Experience successfully leading departmental and cross-functional teams without authority.
• Experience authoring and implementing processes.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.