Senior Associate Regulatory Scientist (Immunology /PH)

工作内容

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Pursuing the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. We are looking for a Senior Associate Regulatory Scientist to provide support for regulatory activities for products in the assigned portfolio, including assuring content and intent of regulatory filings support the global Regulatory Strategy. Key responsibilities include: Input in development, post-approval, and Life cycle management Participate in global regulatory team meetings as appropriate Advise the Regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area Liaison with Regulatory Agencies and Local Operating Companies Act as back-up for contact with Regulatory Agencies as needed Draft cover letters for Regulatory Agency communication Assist in the preparation of meetings with Regulatory Agencies Liaise with LOCs, track and respond to queries in a timely manner Input in document and process development Assist in the the development of processes related to regulatory submissions Draft and review some document content (depending on level of regulatory knowledge/expertise) Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed Track dates of submissions and Regulatory Agency responses Clinical Trial Applications (CTA) Review protocols and ensure alignment with regulatory requirements Advise team on required documents and submission strategies in preparation of CTAs Ensure CTA submission packages are complete and available according to agreed timelines Review and approve clinical trial supply plans Marketing Authorization Applications (MAA) Provide regulatory support throughout the registration process Provide regulatory support throughout life-cycle management Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate) Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities Assist with submission and acceptance of MAA Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans Are you able to demonstrate your technical knowledge in? Submissions Regulatory affairs submission and filing registration process, being able to critically review and compile dossier components with your understanding of dossier component requirements. Understanding submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applications Regulatory Intelligence Using your knowledge of laws, guidance, requirements, and their implications as well as up-to-date knowledge of current and pending approvals in specific TA Regulatory Strategy Provide strategic input and technical guidance on requirements to development teams. You will understand the life cycle (LC) of drug products from discovery through marketing and post-approval requirements and you have the capability to interpret and apply local regulations and guidance’s to the LC of a drug product Health Authority Expertise Knowledge of how Health Authorities operates, their Organizational structure and responsibilities of those in the structure as well as timelines for reviewing submissions Qualifications Qualifications Do you have the following core Experience skills and education? You have a proficient understanding of the drug development process and regulatory submission and approval processes You are educated to degree level in a medical or paramedical (pharmacy, biology, veterinary, etc.), or equivalent by experience; Your experience in the industry will be at least 2- 3 years. Knowledge of the regulatory environment, guidelines, and previous exposure to the European Centralised Procedure process is a plus You are able to work successfully within a team environment and as an individual contributor; Project management skills Oral & written communication skills Organization & multi-tasking skills Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location Netherlands-South Holland-Leiden- Other Locations Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe Organization Janssen Biologics (7266) Job Function Regulatory Affairs Requisition ID 2105957273W