Regulatory Affairs/GCP Specialist - FTC - M/F

Description de l'offre

Johnson & Johnson Santé Beauté France, a member of Johnson & Johnson's Family of Companies, develops and markets consumer healthcare, baby care, and beauty/skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby, BAND-AID® Brand, LISTERINE®, leading skin care brands such as NEUTROGENA®, AVEENO®, CLEAN & CLEAR®, LUBRIDERM® and healthcare products such as NEOSPORIN®, CORTAID®, REMBRANDT® and REACH®.

Johnson & Johnson Santé Beauté France is recruiting a
Regulatory Affairs/GCP Specialist M/F based in Val-De-Reuil (France).

The position is a 4/5-month fixed-term contract.

The main responsibility of this position is ensuring that all products and related activities for J&J consumer group are within the regulatory framework thanks to anticipation, understanding, informing, management of complex situations and application of original solutions while respecting J&J values.

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.

PRINCIPAL MISSIONS
Partner and support of R&D and Marketing before and throughout product development up to commercialization by controlling the consistency and regulatory validity of concepts; by establishing the regulatory needs in terms of claim support in partnership with teams; by assessing testing adequacy with the claims requested by the Marketing; by supporting different departments R&D / T&D from a regulatory perspective.

She/He ensures execution of the regional strategy in line with global strategy and taking into consideration local insights. Key partner of regional Marketing GFO. Indirectly support RFLT plans and is accountable for delivery.

The Regulatory Affairs Specialist ensures validation of all communication support created by Marketing, checking that argument / communication is in compliance with applicable regulations and in close collaboration with local Regulatory Affairs managers and the brand Regulatory Affairs manager.

She/ He generates regulatory documents such as ingredient list, regulatory clearance.
She/He ensures the review of Product file.
She/ He will provide registration support to local RA based in countries outside EU where registration is required.
She/He could also prepare inspections or J&J defence in case of challenge by Authorities or competitors.

Regulatory Affairs Specialist will work, in collaboration with other J&J departments, on transverse technical or regulatory projects.

She/He has a level of autonomy that allows her to manage common requests. For more complex or strategic requests, She/ He consults her manager and applies the approved action plan.

In this specific position, the Regulatory Affairs Specialist oversees project MEGARESTAGE in all regulatory and product registration aspects.

Profil recherché

Qualifications :

PROFILE

Education: Scientific degree preferred (Bac +3 minimum)

Experience:
At least 1 year of experience in Regulatory Affairs within the Cosmetics industry
A first experience with GCP would be a plus

Physical Demands: Office Work

Knowledge, Skills and Abilities:
• Solution oriented and able to work with multidisciplinary team
• Understanding of the regulatory environment is a plus
• Communication skills, ability to connect with other departments in order to build the vision
• English, Microsoft Office