Regulatory Compliance Advisor

Location: Dudley, Northumberland, UKDepartment: Manufacturing and SupplyReference: VN068
Summary of Regulatory Compliance Advisor role
 
Based at our Cramlington, UK site.  Co-ordinating all aspects of chemicals regulatory compliance and product stewardship including REACH, Safety Data Sheets, internal hazard sheets, setting exposure limits, etc. and driving compliance and communication across our business and stakeholders.
 
Responsibilities
 
  • Undertake the role of primary advisor to the business for chemicals regulatory compliance.
  • Determine and deliver the chemical regulatory compliance strategy for site products/materials and processes.
  • Close liaison with supply chain, customers and key stakeholders to ensure chemical regulatory compliance needs are assessed and delivered in line with our business as a contract manufacturing organisation.
  • Prepare substance registration dossiers (using IUCLID) for submission to the UK-REACH system.
  • Select and work with external service providers to support data collection and submission as needed.
  • Provide clear and effective communication to other functions (e.g. Commercial, Procurement, Finance or Manufacturing, etc.) or customers on our compliance obligations, project status and risks, and the impact of future regulatory developments on our compliance strategies.
  • Oversee and coach others in the delivery of management systems and processes to ensure compliance and effective business processes.
  • Evaluate and interpret changes in relevant legislation through attendance at industry/regulator meetings and conferences.
  • Comply with all company health, safety, and environmental requirements.
  • Embody our company values, which are: be reliable, be caring, be transparent and be willing.
 
Key Skills and Competencies
 
  • Bachelor’s degree (or equivalent) in chemistry or a related discipline such as chemical engineering.
  • Keen understanding of the requirements of REACH and CLP regulations and delivery of compliance against them.
  • Appreciation of toxicology and the use of data to set workplace exposure limits or occupational exposure bands.
  • EU and UK-REACH experience combined with regulatory aptitude (e.g. familiarisation with other types of regulatory areas, controlled substances, agrochem, biocides etc).
  • Familiarity with the ECHA and UK-REACH regulatory systems for information management.
  • It would be favourable to have some experience in complex problem-solving REACH issues in dossiers and exposure to other chemicals legislation in other countries – TSCA, China, K-REACH etc is desirable.
  • Ability to communicate and influence effectively including experience of presenting and justifying recommendations to stakeholders, including directly with customer representatives.
  • Excellent problem-solving skills and good judgement in interpreting complex situations.

We also require candidates to be competent with IT systems, and in particular Microsoft Office including Outlook, PowerPoint, Word and Excel.
 
You will receive
 
A competitive salary, pension scheme, Perkbox, cycle to work, 25 days annual leave, death in service coverage, on-site health and wellbeing support and medical consultation and physiotherapy, 24/7 employee assistance programme. Training and opportunities for further career development.

In addition to the remuneration package, the successful candidate will gain significant experience and skills in a fast-moving, multi-product, multi-customer environment.
 

Why consider Sterling?
 
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
 
We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
 
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 
 
Sterling Pharma Solutions is an equal opportunity employer.
 
Be caring. Be transparent. Be willing. Be reliable.
Deadline for applications: 26 Oct 2021
Service. Passion. Science.