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Regulatory Manager - North West

Reference: 2308
 
Location: North West / North Wales
Sector: Regulatory
Job Type: Permanent
 
Contact: Heather McArragher
Consultants Email: heather@whitehall.uk.com
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:
  1. UK REACH 
  2. EU REACH 
  3. USA TSCA, OMRI
  4. Korean REACH 
  5. USA and China INIC 
  6. 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.