Associate Director - SHE Regulated Operations

Macclesfield

At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. We are part of an inclusive and giving community, supporting each other on our journeys. We are leading the way in delivering Lean processes that drive greater efficiency and speed. Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products.

We are now looking for an Associate Director - SHE Regulated Operations to join the team!

Introduction to Role

The role will own the Macclesfield Campus’s regulator-facing licences, permits and Safety, Health and Environment (SHE) compliance obligations, covering environmental regulation, controlled substances, emissions, waste, chemicals, contaminated land and multimodal dangerous goods. It will provide expert regulatory and product stewardship input to Process Technology and Development (PT&D) and Research and Development (R&D) on new substances and novel chemistry, while holding statutory accountability and acting as the primary interface with regulators. The role will also oversee the AI toolset, including routine register maintenance, statutory deadline tracking and correspondence drafting.

Accountabilities

• Hold the consolidated regulator-facing licence and permit estate including EA Environmental Permits trade effluent consent, borehole abstraction licence, and REACH (GB and EU via Only Representative for exports); own the emissions inventory including stack monitoring (MCERTS) and Active Pharmaceutical Ingredients (API) in the environment control.
• Hold the statutory DGSA (Dangerous Goods Safety Adviser) appointment for the Campus — with duty-holder mapping across consignor / packer / filler / loader / carrier / unloader roles; ADR 1.10.3 high-consequence dangerous goods security plan (with Security, where applicable); multimodal competence (IMDG 2-yearly refresh cycle, IATA DGR); higher-risk streams governance (dry ice, UN3373 biological samples, lithium batteries, waste consignments under ADR); haulier and freight forwarder audit programme; TPED compliance for transportable pressure equipment.
• Lead the EA breach-notification workflow — notification-window management, regulator correspondence, and post-breach remediation tracking.
• Own permit-deviation interpretation — assess what the deviation means, whether it triggers notification, what evidence is required, and what corrective action is proportionate.
• Provide evidence-pack sign-off for regulator inspection and audit on the named licence and permit estate.
• Operate the instrumented compliance obligations register, permit-condition tracker, and statutory-clock dashboard; this role validates, judges, and acts.
• Hold the SHE regulatory interface to PT&D and R&D functions on new-substance introduction — regulatory impact assessment for new molecules and novel chemistry, REACH compliance for new substances, Home Office schedule reviews for new controlled substances, and dangerous goods classification for new materials.
• Cross-pillar collaboration with the Sustainability Lead on EA permit and packaging EPR (pEPR) compliance; with the Industrial Hygiene Subject Matter Expert (SME) on COSHH and exposure-related permits.
• Lead the Annual EA Sustainability Improvement Plan submission alongside the Sustainability Lead.
• Own the DGSA, dangerous goods, and controlled drugs training programme for site personnel handling regulated substances — curriculum design, competency assessment, refresher cycles.
• Own environmental waste governance — hazardous waste registration and consignee returns, waste carrier / broker / dealer registrations; the F-gas and Ozone-Depleting Substances (ODS) registers with certified handler oversight and leak-check frequency governance.
• Own contaminated land and groundwater monitoring including historic liability management (with Legal), and nuisance management (odour, noise at boundary, light) with planning condition compliance.
• Hold the site Home Office licensing portfolio — Controlled Drugs (SHE-side handling risk assessment and containment; Quality / Security accountable for licence conditions and safe custody), explosives precursors and poisons, drug precursors (Categories 1/2/3) — with Security interface.
• Assess and manage site position under the Chemical Weapons Convention (Schedule 1/2/3 and DOC declarations, where applicable), and biocidal products regulation for cooling water and disinfection actives; support Trade Compliance on dual-use chemicals and equipment export control screening.
• Where applicable to the Campus (site-specific confirmation required): IRR17 and Radioactive Substances Regulation governance — RPA / RPS appointments, sealed source inventory, radioactive waste routes.
• AZ Pharma environmental peer-network participation.
• External representation in EA regional forums where invited.
• Cross-departmental advice to operations teams on regulatory compliance.
• Support to Director – SHE people, Workplace & Capital on regulator-facing matters.