Manager, Regulatory Operations

Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company’s lead therapeutic, ADI-PEG 20, is a novel biologic in late-stage clinical development in oncology.

We are seeking a manager to oversee regulatory operations activities and to support selected clinical program activities. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required.

Responsibilities:

• Prepare regulatory submissions by formatting, publishing, and compiling regulatory documentation including IND amendments, annual reports, DSURs, IBs, protocols, safety reports, and clinical study reports.

• Submit or manage the submissions for all regulatory documentation to FDA and international regulatory agencies.
• Format MS Word documents using software template tools and established standards.
• Publish PDF submission documents using standards for electronic submissions (currently using GlobalSubmit).
• Compile eCTD submissions.
• Manage QC process and documentation of submissions
• Collaborate with interdepartmental teams to provide support for regulatory submissions.
• Prepare and communicate regulatory submission timelines.
• Prepare or update work instructions and SOPs for regulatory submissions
• Stay current with new electronic submission and regulatory documentation practices issued from regulatory agencies.

• May perform other duties as assigned

Requirements:

• Bachelor’s degree, preferably in science or healthcare
• Minimum of 4 years’ of experience in the biotech/medical diagnostics/pharmaceutical industry or CRO with at least 2 years in regulatory operations

• Experience with Global CTA submissions, especially to the UK.

• Expertise in eCTD format and regulatory submission requirements
• Excellent written and verbal communication skills

Polaris Pharmaceuticals, Inc. does not discriminate in employment opportunities or practices based on race, color, gender, religion, veteran and military status, marital or registered domestic partner status, age, national origin or ancestry, disability, medical condition (including genetic information or characteristics), sexual orientation, or any other characteristic protected by federal, state, or local laws.