Regulatory Affairs Manager

About the Role

Our client is seeking an experienced and strategic Regulatory Affairs Manager to lead their regulatory operations, working remotely and supporting their UK and international markets, including Bristol . This role is crucial for ensuring compliance with all relevant pharmaceutical regulations and for successfully navigating the complex landscape of drug approval and lifecycle management. You will be responsible for developing regulatory strategies, preparing submission documents, and liaising with health authorities. This is an exceptional opportunity for a seasoned regulatory professional to make a significant impact on the company's global product portfolio and growth from a remote-first environment.

Key Responsibilities

• Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTAs, MAAs, NDAs) to national and international health authorities.
• Liaise effectively with regulatory agencies, responding to queries and managing submissions throughout the review process.
• Ensure compliance with all applicable pharmaceutical regulations, guidelines, and internal company policies.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, and manufacturing.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree preferred.
• Minimum of 7 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting successful regulatory applications in key markets.
• In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Excellent strategic thinking, project management, and communication skills.
• Ability to work independently and manage complex projects in a remote setting.

Benefits

• Highly competitive salary and significant performance bonus potential.
• Flexible and supportive remote work environment.
• Comprehensive executive health, dental, and vision benefits.
• Generous retirement savings plan with company contributions.
• Opportunities for professional development, including leadership training and conference participation.