Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client, a dynamic and growing pharmaceutical company, is seeking an experienced Regulatory Affairs Specialist to enhance their regulatory compliance team in Bradford . This role is integral to ensuring that all pharmaceutical products manufactured and marketed by the company adhere to national and international regulatory standards and guidelines. You will be responsible for preparing and submitting regulatory documentation, managing post-approval changes, and liaising with health authorities to facilitate product approvals and lifecycle management. This position offers a significant opportunity to shape regulatory strategies and contribute to the market access of innovative medicines from our Bradford base.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs) and variations to existing marketing authorizations.
• Ensure compliance with current regulatory requirements in key markets, including the UK, EU, and US.
• Manage post-approval regulatory activities, such as annual reports, safety updates, and change controls.
• Liaise with health authorities (e.g., MHRA, EMA, FDA) to respond to queries and facilitate the regulatory review process.
• Monitor changes in the regulatory landscape and assess their impact on company products and strategies.
• Advise internal teams on regulatory requirements and best practices throughout the product lifecycle.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. A Master's degree is advantageous.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
• Thorough understanding of pharmaceutical regulatory requirements, including GMP, GCP, and GLP.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects simultaneously and work effectively under tight deadlines in Bradford .

Benefits

• Competitive annual salary and performance incentives.
• Comprehensive health insurance and wellness programs.
• Generous paid time off and company holidays.
• Opportunities for professional development, including specialized regulatory training.
• A collaborative and growth-oriented work environment within the UK's thriving pharmaceutical sector.