Johnson & Johnson

Multiple industries

4,221 followers

Regulatory Expert at Johnson & Johnson


For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Spain are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Under the 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):
  • Translate environment developments into relevant actions for the CVT and LOC RA, enabling the CVT to optimize the strategy
  • 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
    • Intelligence
    • 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 Companies, 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 deadlines for different projects are met or escalated to the 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

Compliance

  • 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.

Internal contacts

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

External contacts

  • Contribute 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
  • Contribute to initiatives around lessons learned 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

Out of scope for FTE calculation, but potentially part of responsibilities:
  • Review of promotional, corporate, and educational materials when applicable
  • Review of press releases
  • Review of MovileApps
  • Act as a scientific department when international congresses are held in Spain
  • Implementation of the process included in the Guideline 1/2000 abut promotional activities

Report all suspected adverse reactions, serious or nonserious, 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 managed 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 managed, and complied with when planning projects, developing materials, executing projects, and contracting vendors.

Qualifications
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
  • 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

Primary Location
Spain-Community of Madrid-Madrid-
Organization
Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Job Function
Regulatory Affairs
Requisition ID
2105974313W

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