Position: Data Analyst-Marketing 
Location: Short Hills, NJ
Duration: 1 Year

Job Description:

We are seeking a highly skilled and experienced Data Analyst specializing in Marketing to join our team. The ideal candidate will have a strong background in regulatory affairs, particularly in the pharmaceutical, vaccine, or biological products industry. The primary responsibilities of this role include performing CMC compliance activities, authoring assessment reports, and leading global product regulatory strategies. The Data Analyst will also collaborate with clients and external partners to ensure compliant execution of change management and regulatory conformance.

Key Responsibilities:

• Conduct CMC compliance activities including Gap Analysis, CMC comparison, and validation for quality reports.
• Author assessment reports and Part 2/Expert reports for Dossiers.
• Review quality documents such as Reformulation studies, process validations, and stability indicating methods implementation.
• Serve as the CMC Product Lead for assigned products, accountable for the delivery of all regulatory milestones.
• Lead development and execution of global product and project regulatory strategies.
• Collaborate with clients and external partners to support compliant execution of change management.
• Manage execution/authoring of CMC documentation for life cycle management.
• Demonstrate an understanding of regulatory guidelines and relevant applications.
• Identify, communicate, and escalate potential regulatory issues/risks and propose mitigation.
• Ensure compliance with established policies and procedures of the organization/client.
• Demonstrate effective leadership, communication, interpersonal skills, and soft skills.

Qualifications:

Minimum Qualifications:

• Bachelor's or master’s degree in science, engineering, or related field (advanced degree preferred).

Preferred Qualifications:

• Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products.
• Marketing authorization experience.
• Proven Project Management experience.