Regulatory Affairs Specialist M/F

Description de l'offre

Job Description

Requisition ID: 1805686867W

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 250 Johnson & Johnson operating companies employing approximately 130,000 people in 60 countries throughout the world.

If you have the talent and dream to touch the world, Johnson & Johnson has the career opportunities to help you to make it happen.

For our Consumer business, we are hiring a Regulatory Affairs Specialist to be based in Val-de-Reuil (France).

Position summary :

Ensuring that any product and activity provided by J&J consumer group is within the framework of regulations, by anticipating, understanding and management of complex situations with solutions and strategies respecting the internal values of the company credo.

This mission is part of one or several defined brands, in its field of competence from early product development to commercialization, at regional level (EAME) depending on brand size.

What will be your daily responsibilities?

·  Partner and supports R&D and Marketing throughout product development up to commercialization and beyond by
·  ensuring the regulatory validity of concepts; establishing the regulatory needs in terms of claim support in partnership with other stakeholders;
·  assessing the claims requested by the Marketing;
·  supporting different departments from a regulatory perspective;
·  ensuring the successful delivery of non-EU registration support to affiliates and distributors so that they can obtain Product Registrations for launch.
·  Ensure execution of the regional regulatory strategy, taking into consideration the local insights, and ensuring it is in line with global strategy.
·  Indirectly support Regional Franchise Leadership Team plans and is accountable for delivery.
·  Ensure the validation of all communication support created by Marketing, checking that substantiation / communication is in compliance with applicable regulations and in close collaboration with local Regulatory Affairs managers and the Brand Regulatory Affairs manager.
·  Generate regulatory documents such regulatory clearance and ensure the review of Product information file.
·  Provide registration support to local RA based in countries outside EU where registration is required. In this role, the RA Specialist operates by centralizing the registration documentation preparation and ensuring only relevant, compliant and validated documents are issued to the local affiliates within the agreed timelines, by working in close collaboration with the regulatory franchise, manufacturing sites, other J&J departments and approved external partners.
·  Prepare for inspections or challenges by Authorities or competitors.
·  Work, in collaboration with other J&J departments, on transverse technical or regulatory projects.

Profil recherché

Qualifications

Competencies and required training:




·  Chemical Engineer Degree or equivalent
·  0-2 years of related experience in Consumer industry
·  Fluent English
·  The knowledge of regulatory area is important
·  Good communication and business orientation skills are essential
·  Analytical thinking and rigor is a must

Primary Location
France-Haute-Normandie-Eure-
Organization
Johnson & Johnson Santé Beauté France SAS (7101)
Job Function
Regulatory Affairs
Requisition ID
1805686867W