Regulatory Strategy Senior Manager

About this role

Job Description
General Summary:

• Reporting to the Director Regulatory Affairs, Distributor Markets & Geographic Expansion Lead, the RoW Senior Manager (SM) will lead and support submissions in Distributor Markets for MAAs and license maintenance.
• The SM will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices

Key Duties And Responsibilities
Regulatory

• Acts as main contact for submission partners i.e. GCC (KSA, UAE, Kuwait, Bahrain, Qatar, Oman), Russia, Israel, Serbia, North Macedonia, Jordan and additional countries added by the Global Expansion Team
• Lead cross functional Vertex team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
• Act as support to submission lead by preparing timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date
• Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner
• Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as compassionate use, exemption from local labelling, CTA requirements, etc.
• Ensure all work is compliant with regulatory requirements and company policies and procedures

General

• As applicable, support and contribute to local cross-functional and leadership teams to achieve corporate and departmental goals and objectives.
• Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction
• Attend meetings at local or international Vertex Offices
• Exemplify Vertex’s core values in fulfilling these job duties

Knowledge And Skills
Regulatory

• Relevant industry experience in reg...