Senior Regulatory Affairs Specialist

Location

Dallas TX

Type

Full-time

Summary

The Senior Regulatory Affairs Specialist is responsible for leading and executing regulatory activities to support compliance product registrations and lifecycle management activities across applicable markets. This role provides regulatory expertise to support submissions renewals labeling promotional review and ongoing compliance activities while ensuring alignment with regulatory requirements internal procedures and quality standards.

Key Responsibilities

• Lead preparation and management of regulatory submissions for product registrations renewals amendments and post-approval changes.
• Ensure timely and high-quality regulatory approvals and maintenance of product licenses throughout the product lifecycle.
• Prepare and coordinate responses to regulatory authority inquiries and official correspondence.
• Monitor and assess changes in regulatory requirements guidance and industry standards relevant to assigned products and markets.
• Provide regulatory interpretations risk assessments and compliance recommendations to internal stakeholders.
• Support ongoing compliance of marketed products throughout their lifecycle.
• Review and approve labeling packaging artwork instructions for use (IFUs) and related documentation to ensure compliance with applicable regulations and approved registrations.
• Support review and approval of promotional educational and marketing materials in accordance with regulatory and internal requirements.
• Provide regulatory support for business initiatives customer requests and commercial activities as required.
• Serve as a regulatory point of contact for internal teams customers and regulatory authorities.
• Collaborate cross-functionally with Quality Clinical Marketing Supply Chain and other departments to support regulatory objectives.
• Contribute to process improvements SOP updates and regulatory best practices.

Required Qualifications & Experience

• Bachelors degree in Life Sciences Pharmacy Biomedical Engineering Regulatory Affairs or a related field.
• Experience in Regulatory Affairs within the medical device pharmaceutical biotechnology or related healthcare industry.
• Knowledge of regulatory submission processes and applicable regulatory frameworks.
• Strong organizational skills with the ability to manage multiple projects and priorities simultaneously.
• Excellent written and verbal communication skills.

Preferred Skills & Competencies

• Regulatory Compliance & Submission Management
• Product Registration & Lifecycle Management
• Regulatory Risk Assessment & Problem Solving
• Technical & Regulatory Writing
• Stakeholder Communication & Relationship Management
• Attention to Detail & Documentation Accuracy
• Ability to Work Cross-Functionally
• Process Improvement & Continuous Learning
• Professionalism Confidentiality & Ethical Conduct

Prosperity thanks all applicants for their interest in this opportunity. However only those selected for further consideration will be contacted.

Prosperity is committed to the principles of equal employment opportunity and affirmative action. We value diversity and are dedicated to fostering an inclusive workplace.

Candidates must be legally authorized to work in the United States.