Johnson & Johnson Careers
Descripción del Trabajo
Requisition ID: 1905747668W
Under supervision of the Head, the RE is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:
• Dedicated to (a set of) TAs, both for development, in-Market and Established products;
• Always part of the core CVT (attend CVT meetings where relevant, based on the agenda):
o Translate environment developments into relevant actions for the CVT and LOC RA, enabling the CVT to optimize the strategy;
o Ensure that, where relevant local issues are identified as potentially impacting RA strategy, these are highlighted to IBVT RA, to ensure that the IBVT RA strategy can be implemented smoothly.
• Ensure fast introduction of new products and line extensions including new indications;
• Keeps overview of all TA specific activities:
Monitoring implementation of procedures;
Ensure regulatory compliance;
TA specific shaping of RA environment (together with EMEA);
Operational contact with authorities, etc.).
• Key IBVT, RA Liaison contact for their TA;
• Regulatory support for the products licensed to other Company, if applicable.
1.1 MAIN ACTIVITIES/TASKS:
New and existing products
• Provide strategic input by participation in internal (e.g. CVTs, LLCM) working groups to meet company objectives;
• Ensure deadlines for different projects are met or escalated to Head of RA;
• Supervise the creation and the processes for obtaining the approval of a new product;
• Ensure that the key information is provided when a MA is obtained;
• Supervise de creation of product monograph, “Expedientes Clínicos Farmaceúticos” and Expert Statements;
• To perform all required product tasks, following the plan and updates from EMEA, enabling optimal label implementation and maintenance and to make sure CVT is up to date with all relevant RA product-related updates, enabling local strategy optimization;
• Ensure that, where relevant local issues are identified as potentially impacting RA strategy, these are highlighted to IBVT RA, to ensure that the IBVT RA strategy can be implemented smoothly;
• To make sure IBVT RA receives all local RA competitive intelligence with cross-country relevance as well as to make sure CVT gets all relevant competitive intelligence and its interpretation / impact to enable strategic decisions.
• Ensuring optimal compliance to local, regional and Janssen regulations, to minimize risk for the patient and Janssen business;
• Maintain an awareness of regulatory guidelines/directives/national requirements in order to provide appropriate advice.
• Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales);
• Support tender business;
• Contribute to positive relationships with the local health authorities, in general and on product-specific topics.
• Support and contribute to GRA-EMEA initiatives;
• Contribute to initiatives around lessons learnt and change management to ensure efficiency gains;
• Translations, together with the ERMC when applicable;
• Pack-mat activities, together with the ERMC when applicable;
• Distribution of the new versions of the Summary of Product Characteristics to other departments of the company;
• Revision of Annual Product Review;
• Review of promotional, corporate and educational materials, press releases; MovileApps when applicable;
• Act as scientific department when international congresses are held in Spain;
• Implementation of the process included in the Guideline 1/2000 abut promotional activities.
1.4 JOB LOCATION:
• Occasionally flexible work hours and reachable in case of emergencies;
• Readiness to travel; amount of travel is mainly based on a case by case basis.
2.1 ESSENTIAL KNOWLEDGE & SKILLS:
Required education & experience:
University Degree in Pharmacy, Biology, Chemistry or related Life Science
Regulatory Affairs experience (5-8 years).
At least 5 years’ experience in RA with product and/or TA management responsibilities; small team lead experience is an advantage.
- Direct experience and strong knowledge of general regulatory requirements and guidelines;
- Fluent in relevant local language and English
Other skills and abilities:
Analytical / conceptual skills
Product RA legislation knowledge
Knowledge, understanding and interpretation of legislation
Awareness and ability to understand the broader picture on compliance and launch time
CVT relation builder
Excellent internal communication & presentation
España-Comunidad de Madrid-Madrid-
Janssen-Cilag S.A. (formerly Janssen Sp) (7300)