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 regulatory affairs, across the lifecycle, and understanding of current trends in local and regional requirements. Recognized as a knowledgeable resource for regulatory advice by other departments Experience of managing negotiations with Regulatory Authorities Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (mainly submission partners) General Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society. Good interpersonal skills and ability to deal effectively with a variety of personalities. Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements. Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans. Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects. Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others. Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity. Proactively identify risks and develop potential solutions Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct. Ability to navigate and be successful in a fast-paced environment while delivering high quality results. Excellent communication skills, strong oral/written presentation skills. Fluent written and spoken English. Education and Experience: Bachelor’s degree in life sciences or M.Sc. or Ph.D. degree Typically requires solid experience in relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience #LI-SG1 #LI-Hybrid Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.