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Regulatory Affairs Associate, Bnl
Il y a 16 minutes
Working in partnership with Global Regulatory, and under the responsibility of the RA manager Personal Care FR and BNL, You will be a key point of contact to Global Regulatory and local Regulatory teams with respect to cosmetic, detergent and biocides regulation, relaying knowledge about external factors and internal impact on processes and timings.
You will enable the local and global teams by providing visibility and understanding of regulatory requirements and status, translating regulation into business language in order to drive clarity in markets to partnering functional stakeholders.
The role will have the following responsibilities:
- Advice and assistance on regulatory aspects to the departments concerned (development, production, quality, marketing, sales...)
- Management of specific and varied regulatory requests on the portfolio (cosmetics, biocides, detergents )
- Coordination of the constitution of Biocides files, in close relation with the consultant, the R and D teams and the global regulatory department
- Preparation, review and Submission of Biocides files in Belgium and Luxembourg to Health Authorities
- Control of the regulatory compliance of the advertising material (digital communication, TVC, social media )
- Elaboration, validation, and dissemination of texts related to packaging items (Artwork), product information and safety data sheets
- Drafting and review of internal procedures inherent to the regulatory activity
- Management of internal databases (change control, risk assessment and archiving of files and regulatory information) according to Reckitt Global Regulatory Policy.
- Collaborate with partner functions (marketing, supply ) to agree market specific data requirements and delivery timelines
- Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
- Deal with requests and support required documentations from queries raised by France and Benelux Competent Authorities
- Regulatory Assessment and input into Regulatory Intelligence Records after alignment with the manager
- As required, participation to local Trade Associations meeting, conduct reviews Intelligence and initiatives and internal communication of impact assessment at local and global levels.
- Share regular updates and progress of the files during functional team meetings and with the manager
**Professional qualifications / experience**:
A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised, in law, medicine, pharmacy, engineering or another relevant scientific discipline. At least 2 / 3 years of professional experience in regulatory affairs or in quality management systems relating to cosmetics and biocides
Technical skills:
- Knowledge and experience of EU cosmetics and biocides regulatory environments, how it impacts regulatory dossiers and registrations and have the ability to communicate these requirements effectively.
- Knowledge of submission processes and product life cycle management activities for various consumer product categories.
- Experience in preparing and submitting biocides dossiers will be a plus
- Business partnership, flexibility to fulfil business needs whilst ensuring compliance, proactivity, ability to work in a cross-functional environment
**Equality**:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
