Manager, Global Regulatory Scientist - Regulatory Affairs

Responsibilities Draft cover letters and support the preparation of various applications (e.g., IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions. For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings. For Marketing Authorization Applications (NDA, MAA or other major HA submissions): Provide regulatory support throughout the registration process. Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned (in collaboration with LOCs as appropriate). Assist with timely NDA, MAA (other) availability, ensuring that all document components are in place on time and identifying and tracking critical‑path activities. Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other). Ensure country‑specific submission packages are made available to the LOCs in accordance with agreed plans. Assist in the preparation of meetings with Regulatory Agencies. Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high‑quality and timely responses. May include other activities as delegated by the RRL/GRL. Liaise with LOCs, track dates of submissions/responses to queries in a timely manner. Act as back‑up contact/representative on specific multidisciplinary teams, or with regulatory agencies as needed. May be responsible for organizing and leading meetings. Provide regulatory input for and appropriate follow‑up to inspections, audits, litigation support, and product complaints. Support the GRL(GRT) by driving high project‑management planning of global submissions or Health authority interactions and additional major regulatory milestones. Participate in global regulatory team meetings as appropriate. Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs). Advise the Regulatory team on applicable regulatory requirements, project‑specific regulatory issues as assigned. Partner with regulatory colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease‑area‑specific issues. May assist in the development and improvement of regulatory processes. Requirements A Bachelor's degree in a scientific or equivalent discipline; advanced scientific degree is preferred, and at least 6 years of health‑regulated industry experience, or a Master's degree and a minimum of 5 years of health‑regulated industry experience or a PhD/PharmD with a minimum of 4 years of health‑regulated experience. At least 4 years of relevant regulatory affairs experience in the pharmaceutical/biotech industry is required. Knowledge of the regulations and processes of multiple global health authorities would be ideal. Solid understanding of FDA and ICH regulatory requirements and guidelines specific to the areas of clinical research, product development, life‑cycle submission management and product labeling is required. Therapeutic‑area experience in oncology is beneficial. Experience with combination products (drug and device) would be an asset. Intellectual curiosity and an ability/flexibility in learning new things and working in novel areas with limited regulatory precedence. This role will include an opportunity to flex across different product types (pharma, devices, combo products). Experience preparing responses to health authorities, managing Health Authority interactions, and life‑cycle management of clinical trials and marketing authorizations submissions (e.g., IND/CTAS/NDA/BLA, MAA). Experience in strategic planning, technical data summary and cross‑functional management is required. Core Competencies Demonstrates expertise in regulatory affairs with a strong focus on preparing and submitting applications to global health authorities, including IND, CTA, NDA, and MAA. Possesses a solid understanding of FDA and ICH regulations, along with experience in strategic planning and managing interactions with health authorities. #J-18808-Ljbffr Jobtailor