Regulatory Affairs Specialist

About the Company

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. We are powered by our people, and together, we go beyond to make a difference to patients’ lives and society.

Job Description

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our dynamic team in Sunderland. In this pivotal role, you will be responsible for ensuring the regulatory compliance of our products throughout their lifecycle. You will navigate complex regulatory landscapes, interpret guidelines, and develop robust strategies to support product registration, maintenance, and expansion. This position offers a unique opportunity to contribute to life-changing medicines and collaborate with cross-functional teams globally.

Key Responsibilities

• Prepare, review, and submit regulatory documents to health authorities (e.g., MHRA, EMA) for new drug applications, variations, renewals, and other submissions.
• Interpret and apply relevant regulations, guidelines, and directives to ensure product compliance.
• Liaise effectively with global regulatory counterparts, R&D, manufacturing, quality assurance, and commercial teams.
• Manage regulatory projects, timelines, and deliverables to meet business objectives.
• Assess the impact of new and evolving regulations on company products and operations.
• Participate in regulatory intelligence gathering and dissemination activities.
• Provide expert regulatory advice and guidance to internal stakeholders.
• Support the preparation for and participate in regulatory inspections and audits.

Required Skills

• Bachelor's degree in a life science, pharmacy, or related field.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• In-depth knowledge of UK and EU pharmaceutical regulations and guidelines (e.g., MHRA, EMA, ICH).
• Proven experience in preparing and submitting regulatory dossiers (e.g., CTD/eCTD).
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly.
• Strong analytical and problem-solving abilities, with meticulous attention to detail.
• Ability to manage multiple projects simultaneously and work effectively under pressure.

Preferred Qualifications

• Master's degree or PhD in Regulatory Affairs or a related scientific discipline.
• Experience with specific therapeutic areas (e.g., Oncology, Respiratory, CVRM).
• Familiarity with global regulatory requirements (e.g., FDA, Health Canada).
• Proficiency with regulatory submission software and databases.

Perks & Benefits

• Competitive annual salary and performance-based bonus.
• Generous pension scheme with employer contributions.
• Private medical insurance and comprehensive health and wellbeing programs.
• 25 days annual leave plus bank holidays, with options to buy/sell leave.
• Employee assistance program and mental health support.
• Subsidised on-site gym and cafeteria facilities.
• Opportunities for professional development, training, and career progression.
• Company share schemes and discounts.

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