Regulatory Manager

5 days ago

Manchester, United Kingdom FPSG Connect Full time

**Overview**

**Ref:97974**

**Regulatory Manager**

**Role responsibilities**
- To ensure compliance of product portfolio to applicable regulations, guidelines, and internal standards, especially taking in consideration requirements for different countries around the world
- Set up and implement regulatory strategy regarding the life cycle management and registration of new products.
- Plan and coordinate the preparation & submission of registration and compliance dossiers. Follow and achieve registrations for the product portfolio according to plan. This includes defining the regulatory requirements for local submission of registrationdossiers.
- Liaising with colleagues and external labs to ensure correct analysis and testing is performed.
- Dossier compilation, authoring, regulatory compliance, initiation of publishing by using electronic databases & repositories and submission to authorities on a global basis.
- Updating and maintaining registration dossiers post registration. This will include the submission of variation submissions.
- Ensuring the renewal of registration products by defining the accurate timelines based on the current requirements.
- Maintaining and updating regulatory files and records including archiving of all relevant documentation in the respective databases in accordance with legal obligations and internal standards.
- Advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions.
- Review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements, especially the PAGB code of practice and the CAP.
- Liaise with authorities, distributors, regulatory authorities, trade associations and contract manufacturers in the region, to achieve and maintain registrations.
- Develop relationships with regulatory and industry bodies to represent the interests of the organization, gain relevant information and help shape change.
- Provide relevant regulatory advice especially in product development projects.
- Keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional, and local environment in order to ensure organizational compliance.
- Evaluate and give regulatory input to specific products requirements (like reimbursement and fixed prices considerations).
- Involve in the education/training of new colleagues and other functions.

**Person Specification**
- Experience in global market chemical regulations examples but not limited to
- UK REACH
- EU REACH
- USA TSCA, OMRI
- Korean REACH
- USA and China INIC
- CLP/GHS
- New global regulations strategies
- Knowledge of chemical development process and regulatory affairs.
- Knowledge of the commercial and technical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities.
- Understands the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.
- Has an in-depth understanding of regulatory and safety governance.

**Next Steps**

**Equal Opportunities**

FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.

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