Regulatory Manager - North West
Reference:
2308
Location:
North West / North Wales
Sector:
Regulatory
Job Type:
Permanent
Contact:
Heather McArragher
Salary:
up to £50,000 (in line with experience)
Our Client is a biotechnology company that produces 100% biodegradable surfactants from renewable feedstocks which can be used in a variety of applications from hard surface cleaners to face creams, shampoos and conditioners. They have research and development facilities, pilot plant and a commercial plant located in various locations in the North West.
This position will preferably be based in Manchester, a role in Wallasey could be considered.
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 registration dossiers
- 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).
Candidate Profile
- 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.
Salary up to £50,000. Benefits: Share options, 25 days holiday plus BH, healthcare after 2 years’ service, company pension and sick pay.
Whitehall is the Recruitment Specialist for the Chemicals, Resins, Pigments, Coatings, Polymers, Pharmaceutical and Science based Industries.