Talent-Network-Button
divider

Johnson & Johnson Careers

Regulatory Expert

Madrid, España
Regulatory Affairs


Descripción del Trabajo

Requisition ID: 1905709942W

Overall purpose of job:


Under supervision of the Head of Regulatory Affairs, the RE is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:


  • You will be dedicated to (a set of) TAs, both for development, in-Market and Established products
  • You will be a part of the core Country Value Team (attend CVT meetings where relevant, based on the agenda):
- You will translate environment developments into significant actions for the CVT and LOC RA, enabling the CVT to optimize the strategy
- Where important local issues are identified as potentially impacting RA strategy, you ensure these are highlighted to IBVT RA, to guarentee that the IBVT RA strategy can be implemented smoothly:

  • You will ensure the fast introduction of new products and line extensions including new indications
  • In this position, you will keep overview of all TA specific activities:
- Monitoring implementation of procedures
- Ensure regulatory compliance
- Intelligence
- TA specific shaping of RA environment (together with EMEA)
- Operational contact with authorities, etc.).

  • As Regulatory Expert you are the key IBVT, RA Liaison contact for their TA
  • You will provide regulatory support for the products licensed to other Company, if applicable

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 that deadlines for diverse projects are met or raised 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.
  • Perform all required product tasks, following the plan and updates from EMEA, enabling optimal label implementation and maintenance and to guarantee CVT is up to date with all significant 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

Compliance

  • Ensure 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.

Internal contacts

  • Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales)
  • Support tender business


External contacts

  • Supply to positive relationships with the local health authorities, in general and on product-specific topics.
  • Healthcare professionals and hospitals


Miscellaneous

  • Support and contribute to GRA-EMEA initiatives
  • Give support to initiatives around lessons learnt and change management to ensure efficiency gains
  • Translations
  • Pack-mat activities
  • Distribution of the new versions of the Summary of Product Characteristics to other departments of the company.
  • Revision of Annual Product Review


Out of scope for FTE calculation, but potentially part of responsibilities:


  • Review of promotional materials


Report all suspected adverse reactions, serious or non serious, I may be aware of within a maximum of 24 hours after being aware of it and communicate it to the Pharmacovigilance Department.


Additionally, for all employees involves in RRAs activities:


  • Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately handled when planning projects, developing materials, executing projects and contracting vendors.
  • Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately handled and complied with when planning projects, developing materials, executing projects and contracting vendors.
  • Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description



Calificaciones


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


Skills and abilities:

  • Analytical / conceptual skills
  • Helicopter view
  • 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
  • Result driven
  • Excellent internal communication & presentation
  • Socially smart, influencer


Special requirements:

Fluent in local language and English


Ubicación principal
España-Comunidad de Madrid-Madrid-
Organización
Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Área
Regulatory Affairs
Requisition ID
1905709942W