Preferred Locations : Warsaw (Poland), Leiden (NL), Beerse (Belgium) or High Wycombe (UK)
Pay Grade : 25
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 a 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 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 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?
Regulatory affairs submission and filing registration process, being able to critically review and compile dossier components with your understanding of dossier component requirements.
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
Provide strategic input and technical guidance on requirements to development teams. You will understand life cycle (LC) of drug product 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
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;
You experience in 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.
Netherlands-South Holland-Leiden- Other Locations
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
Open Positions from Johnson & Johnson Family of Companies