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.

• 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.

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.