The Fountain Group
Remote Associate Director Global Regulatory Affairs
The Fountain Group, Cambridge, Massachusetts, us, 02140
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.
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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.
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