Regulatory Affairs Manager

About the Role

Our client is seeking an experienced and strategic Regulatory Affairs Manager to lead their regulatory team. This role is primarily remote, offering flexibility while requiring strong leadership to guide the team in navigating complex regulatory landscapes for pharmaceutical products. You will be responsible for developing and executing regulatory strategies, ensuring global compliance, and fostering effective relationships with health authorities. This is an excellent opportunity for a seasoned professional to make a significant impact on the company's global product strategy and market access, working within a fully remote, collaborative structure.

Key Responsibilities

• Develop and implement global regulatory strategies for product development and lifecycle management.
• Lead and mentor a team of regulatory affairs professionals.
• Oversee the preparation, submission, and maintenance of regulatory filings in key international markets (e.g., EU, US, Canada, Japan).
• Ensure compliance with all applicable pharmaceutical regulations and guidelines, including ICH.
• Serve as the primary point of contact for health authorities during regulatory interactions and inspections.
• Stay abreast of evolving regulatory requirements and advise senior management on strategic implications.

Requirements

• Advanced degree (Master's or PhD) in a relevant scientific discipline (e.g., Pharmacy, Biology, Chemistry).
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in managing regulatory submissions for various product types (e.g., NCEs, generics, biologics).
• Extensive knowledge of international regulatory requirements and guidelines.
• Strong leadership, project management, and strategic thinking skills.
• Excellent communication, negotiation, and influencing abilities.

Benefits

• Highly competitive executive salary and bonus opportunities.
• Full remote work arrangement with flexible hours.
• Premium health, dental, and vision insurance.
• Generous paid time off and holidays.
• Comprehensive retirement savings plan and life insurance.