Remote Associate Director Global Regulatory Affairs

The Fountain Group; Cambridge (MA); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading healthcare consultancy is seeking a Regulatory Affairs Lead to oversee regulatory strategies and FDA submissions. The ideal candidate will have over 8 years of experience in the pharmaceutical industry, including significant regulatory experience. This role offers a remote working arrangement and an hourly rate of $110-137, with an initial 7-month contract that may extend based on performance.

Qualifications

• 8+ years of pharmaceutical industry experience, with at least 6 in regulatory affairs.
• Experience managing major regulatory filings.
• Strong knowledge of FDA regulations.

Responsibilities

• Lead the Regulatory Working Team and represent it at the GDT.
• Serve as the primary FDA contact for assigned projects.
• Accountable for U.S. FDA submissions and approvals.

Skills

Project management

Strong communication skills

Negotiation skills

Problem-solving skills

Leadership abilities

Education

Bachelor’s degree in a scientific field

Advanced degree (preferred)

Job description

Overview

• 7-month contract to start with the possibility of extension or conversion depending on performance and budget
• Rate: $110-137 an hour
• Location: Remote

Responsibilities

• Lead or oversee the Regulatory Working Team, representing the team at the GDT to ensure regulatory strategies are developed and executed.
• Serve as the primary FDA contact for assigned projects, leading and managing agency meetings.
• Accountable for all U.S. FDA submissions and approvals, including major submissions (NDA, BLA, MAA); may oversee staff responsible for execution.
• Ensure regulatory deliverables are met across non-U.S. Americas territories by coordinating with local affiliates.
• Collaborate with EU co-leads and other regional counterparts to author and execute global regulatory strategies, ensuring alignment across territories.
• Identify regulatory requirements, provide guidance to development teams, and ensure compliance across assigned projects.
• Act as regulatory reviewer during due diligence for licensing opportunities.
• Provide oversight to ensure compliance of marketed products with global regulatory standards.
• Present updates and recommendations to senior management as requested.
• Supervise and mentor direct reports, providing leadership and professional development support.
• Identify resource gaps for projects and propose solutions to maintain compliance and delivery timelines.

Qualifications

• Bachelor’s degree in a scientific or related field required; advanced degree preferred.
• Minimum of 8 years of pharmaceutical industry experience, including at least 6 years in regulatory affairs (or combination of regulatory and related experience).
• Demonstrated experience managing major regulatory filings and contributing to regulatory strategies.
• Strong knowledge of the drug development process, FDA and international regulations, and post-marketing requirements.
• Proven ability to interpret complex scientific and regulatory issues across multiple projects.
• Strong oral and written communication skills with the ability to present to senior management.
• Effective project management and organizational skills, with proven ability to meet timelines.
• Strong negotiation, adaptability, and problem-solving skills.
• Demonstrated leadership experience with the ability to manage teams and align stakeholders to common objectives.
• Collaborative approach with global teams and cross-functional partners.
• Ability to proactively identify regulatory issues and provide creative solutions, including risk mitigation strategies.