GRA CMC Lead driving regulatory strategies for pharmaceutical and vaccine products. Collaborating with cross - functional teams and directly influencing drug approvals through negotiations.
About the role
- Regulatory Compliance Lead managing documentation and compliance operations across North America and LATAM. Leading a team to ensure regulatory standards and documentation accuracy.
Responsibilities
- Oversee daily operations and strategic development of the Regulatory Compliance and Document Management function across North America
- Manage a team responsible for product setup, supplier documentation, TraceGains management, and regulatory surveillance activities
- Ensure accuracy, compliance, and efficiency in supporting customer and supplier documentation needs
- Lead a team responsible for product setup, supplier documentation management, and document approvals
- Develop and monitor metrics related to document turnaround time, accuracy, and compliance rates
- Oversee document acquisition, review, and approval for all supplier documents
- Monitor expired or missing documents and ensure proactive resolution
- Track and communicate relevant regulatory changes across North America and LATAM
- Represent Regulatory Compliance in customer-facing meetings and provide regulatory documentation as needed
- Facilitate communication and document flow between proactive and reactive teams to improve efficiency
Requirements
- Bachelor’s or Master’s degree in Regulatory Affairs, Chemistry, Biology, Food Science, or related field
- 7+ years of experience in Regulatory Affairs, Documentation Management, or Quality Systems within food, chemical, or cosmetics industries
- Strong understanding of North American regulatory frameworks (FDA, Health Canada, etc.); exposure to LATAM a plus
- Proven ability to manage and develop high-performing teams
- Experience with documentation management tools such as TraceGains, SharePoint, or ERP systems
- Exceptional communication and organizational skills; customer-facing experience strongly preferred
- Proficiency in Spanish, French, or Portuguese a plus.
Benefits
- Paid parental leave
- Education assistance program
- Employee assistance program
- Various healthcare plan options
- 401(k)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Manager of Regulatory Affairs driving regulatory strategies for product launches and compliance. Collaborating with cross - functional teams to enhance product development and advertising campaigns.
Compliance Senior Advisor assessing regulatory risks and providing compliance guidance for Atlantic Union Bank. Managing compliance risk assessments and collaborating with business units.
Senior Manager providing strategic regulatory advice for promotional issues at Bristol Myers Squibb. Ensuring compliance with policies, guidelines, and regulations relevant to pharmaceutical promotion.
Analyst supporting Global Customs & Trade Compliance at Bristol Myers Squibb. Focus on coordinating customs and trade management and data generation for import/export operations.
Analyst supporting Global Customs & Trade Compliance at Bristol Myers Squibb. Focused on customs coordination, data management, and regulatory compliance in a pharmaceutical context.
Digital Technology Senior Specialist focused on regulatory compliance in energy technology. Collaborating with product teams and ensuring audit preparedness and structured frameworks for SOC2, EU AI Act, and more.
Regulatory Affairs Officer leading compliance for PayJoy's credit products in Indonesia's fintech landscape. Interfacing with regulators and ensuring adherence to local financial regulations.
Contracts Manager responsible for managing regulatory contracts in compliance for credit provider in emerging markets. Collaborating with teams to ensure legal soundness and risk management in business transactions.
Senior Governance, Risk & Compliance Manager at Nect, an IT company in Hamburg. Responsible for compliance reporting and managing risk in a regulated environment.