Senior Regulatory Affairs Specialist

About the Role

Our client is seeking an experienced Senior Regulatory Affairs Specialist to join their dynamic and fully remote team. This pivotal role will focus on ensuring our client's pharmaceutical products comply with all relevant national and international regulations. You will be instrumental in guiding product development and lifecycle management through expert regulatory strategy and submission execution. This is an exciting opportunity for a motivated professional to contribute to bringing life-saving and life-enhancing medications to market, working from the comfort of their own home while collaborating with a global team.

Key Responsibilities

• Develop and implement regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities such as the MHRA, EMA, and FDA.
• Liaise with regulatory agencies during the review process, responding to queries and addressing deficiencies.
• Monitor changes in the regulatory landscape and assess their impact on company products and operations.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Commercial.
• Ensure ongoing compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) from a regulatory perspective.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets.
• In-depth knowledge of UK, EU, and US pharmaceutical regulations.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects simultaneously and work effectively in a remote, collaborative environment.

Benefits

• Competitive annual salary commensurate with experience.
• Opportunity to work fully remotely with flexible working hours.
• Comprehensive private medical and dental insurance.
• Generous pension scheme and life assurance.
• Professional development budget for conferences and training.