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. Proud to be an equal opportunity employer Why role is vacant:
We are looking for a Regulatory Scientific Manager 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:
- Advising the regulatory team on applicable regulatory standards, project specific regulatory issues.
- Developing an understanding of the regional regulatory environment, competitor intelligence and therapeutic area (TA).
- Drafting cover letters for Regulatory Agency communication;
- Assisting in the preparation of meetings with Agencies;
- Liaising with LOCs, and ensure responses to queries are made in a timely fashion, and that content is consistent with the regulatory strategy.
- Assisting in development and improvement of processes related to regulatory submissions.
- Reviewing clinical trial plans and protocols and ensure alignment.
- Providing regulatory support throughout registration process and life-cycle management;
- Advising team in required documents and submission strategies (in collaboration with LOCs as appropriate)
- Assisting with timely availability of submission documents and ensure that all document components are in place on time
- Drafting and reviewing document content (depending on level of regulatory knowledge/expertise)
- Preparing, hold and lead cross functional team meetings as appropriate
- Understanding submission details and liaise with Submission Management
- Reviewing and approving submission plans and documents to ensure compliance with regulatory standards
- Assisting with submission and acceptance of the submission package
- Ensuring country-specific submission packages are made available to the LOCs in accordance with agreed plans.
Regulatory affairs submission and filing registration process, you be able to critically review and compile dossier components with your understand dossier component requirements.
Understanding submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applications
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
Knowledge of how Health Authorities operates, their Organizational structure and responsibilities of those in the structure as well as timelines for reviewing submissions
- You have a proficient understanding of the drug development process and regulatory submission and approval process
- 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 lease 3-5 years’.
- You are able to work successfully within a team environment and as an individual contributor;
- It is essential that you have previous exposure to the European Centralised Procedure process
- Previous experience in Oncology therapeutic area is preferred
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.
United Kingdom-England-High Wycombe-50-100 Holmers Farm Way
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Cilag Ltd. (7360)