Regulatory Affairs Manager

About the Role

Our client is seeking an experienced Regulatory Affairs Manager to lead their regulatory strategy from their Stoke-on-Trent office. This hybrid role requires a strategic thinker who can navigate complex global regulatory landscapes to ensure timely approval and lifecycle management of pharmaceutical products. You will be responsible for developing and implementing regulatory strategies, preparing submission dossiers, and liaising with health authorities. This position offers a dynamic work environment with the flexibility of remote work for certain tasks, balanced with essential in-office collaboration and team leadership.

Key Responsibilities

• Develop and execute global regulatory strategies for product development and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., NDAs, MAAs, variations) to health authorities worldwide.
• Act as the primary point of contact with regulatory agencies, managing communications and responses.
• Ensure compliance with all applicable regulations and guidelines throughout the product lifecycle.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor changes in the regulatory environment and assess their impact on the company's portfolio.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, Japan).
• In-depth knowledge of international regulatory guidelines and submission requirements.
• Excellent leadership, project management, and negotiation skills.
• Strong written and verbal communication skills, with the ability to influence and collaborate effectively.

Benefits

• Competitive executive-level salary and bonus program.
• Hybrid work arrangement providing flexibility.
• Comprehensive benefits package including health, dental, vision, and life insurance.
• Generous pension scheme and share options.
• Opportunities for career advancement and leadership development.