Johnson & Johnson Careers
Regulatory Affairs Manager (M1)
Requisition ID: 1805673138W
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. We pursue the most promising science.
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking for a Regulatory Affairs Manager /EMEA Regulatory Scientist within the EMEA NCM TA. You will be responsible to provide support to the EMEA Regulatory Liaison and the EMEA Therapeutic Area Leader for a variety of regulatory activities within the Neuroscience, Cardiovascular & Metabolism portfolio supporting assigned CVM products within the NCM team.
You will work on the development of early phase drugs and clinical trials (Phase 1-3) supporting future centralized marketing authorizations, new indications, variations, and other lifecycle procedures, as well as supporting submissions to other markets in EMEA . There is also the opportunity contribute to the development of early phase drugs in the Neuroscience and Cardiovascular Metabolism therapy areas.
Providing support and advice on regulatory issues, to colleagues within Global R&D and to the EMEA region affiliates. The role will require that you will keep tabs on emerging legislation and highlight the potential impact on the business.
You have good all round general regulatory affairs experience, with a sound understanding of the drug development process, and a detailed knowledge and familiarly of the European and EMEA regulatory framework, including the centralized procedure and clinical trial applications. .
We are looking for a flexible in approach, and able to work in a dynamic and fast paced environment. Excellent interpersonal, verbal and written communication skills are essential. You will also require robust regulatory expertise and problem-solving capabilities that will enable successful development of regulatory strategies and technical solutions to support the business and keep the company ahead. You will have the ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key partners.
Input in development, post-approval and life cycle management
- Participating in global regulatory team meetings.
- Advising the regulatory team on applicable regulatory requirements and project specific regulatory issues
- Develop an understanding of regulatory environment, competitor intelligence and therapeutic area.
LIAISON WITH REGULATORY AGENCIES AND LOCAL OPERATING COMPANIES
- Act as back-up for contact with RA as needed
- Draft cover letters for Regulatory Agency communication
- Assist in the preparation of meetings with RA
- Liaise with LOCs, ensure responses to queries are made in a timely manner and content is consistent with the regulatory strategy.
INPUT IN PROCESS DEVELOPMENT
- Assist in development and improvement of processes related to regulatory submissions
- Review clinical trial plans and protocols and ensure alignment with regulatory requirements
Health Authority Submissions (e.g. Briefing Books, Scientific advice packages, Marketing Authorization Applications)
- Provide regulatory support throughout registration process and life-cycle management
- Advise team on required documents and submission strategies (in collaboration with LOCs as appropriate)
- Assist with timely availability of submission documents and ensure that all document components are in place on time
- Draft and review some document content (depending on level of regulatory knowledge/expertise)
- Prepare, hold and lead cross functional team meetings as appropriate
- Understand submission details and liaise with Submission Management
- Review and approve submission plans
- Review of submission documents to ensure compliance with regulatory requirements
- 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.
- Providing regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
- Serving as the Regulatory representative on specific multi-discipline teams
- Keep tabs on current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidance’s and requirements related to those areas.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)