Regulatory Affairs Manager - Biologics & Vaccines

Health, Inc; Waltham (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Health, Inc. in Massachusetts seeks a Manager, Regional Regulatory Lead to develop and execute regulatory strategies for biotherapies, vaccines, and plasma-derived therapies within designated regions.

You will lead dossier preparation, coordinate with health authorities, and guide cross-functional teams through development and lifecycle management. The role requires monitoring evolving regulations to ensure ongoing compliance and supporting inspections and audits to uphold regulatory standards

Qualifications

• Strong knowledge of regional and global regulatory requirements for biotherapies and vaccines.
• Experience in regulatory strategy development, dossier preparation, and submission processes.
• Excellent communication and stakeholder management skills.
• Ability to interpret and adapt to changing regulatory landscapes.
• Collaborative mindset with attention to detail and compliance standards.

Responsibilities

• Lead dossier preparation, submission, and maintenance to meet regional and global requirements.
• Liaise with health authorities to facilitate approvals and respond to inquiries.
• Provide strategic regulatory guidance to cross-functional teams to support development and lifecycle management.
• Monitor and interpret evolving regulations to ensure ongoing compliance.
• Support inspections and audits to ensure regulatory standards are met.

Skills

Regulatory knowledge

Regulatory strategy

Stakeholder management

Regulatory changes

Collaboration & compliance

Job description

Role Overview

The Manager, Regional Regulatory Lead is responsible for developing and executing regulatory strategies for biotherapies, vaccines, and plasma-derived therapies within designated regions.

Key Responsibilities

• Lead the preparation, submission, and maintenance of regulatory dossiers to ensure compliance with regional and global requirements.


• Serve as a primary liaison with health authorities to facilitate approvals and address inquiries.


• Provide strategic regulatory guidance to cross-functional teams to support product development and lifecycle management.


• Monitor and interpret evolving regulations to ensure ongoing compliance.


• Support inspections and audits, ensuring adherence to regulatory standards.

Qualifications & Skills

• Strong knowledge of regional and global regulatory requirements for biotherapies and vaccines.


• Experience in regulatory strategy development, dossier preparation, and submission processes.


• Excellent communication and stakeholder management skills.


• Ability to interpret and adapt to changing regulatory landscapes.


• Collaborative mindset with attention to detail and compliance standards.