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Senior Regulatory Affairs Specialist

2 months ago

Springfield, New Jersey, United States Evergreen Theragnostics Full time

Regulatory Affairs Manager

Company Overview

Evergreen Theragnostics, Inc. is a leading radiopharmaceutical organization based in Springfield, NJ. We operate within a modern, advanced facility, delivering contract development and manufacturing services tailored for radiopharmaceutical enterprises, including therapeutic solutions and centrally distributed diagnostics. Additionally, we manage innovative cancer research laboratories dedicated to the development of proprietary radiotherapeutic medicines. The company is poised for significant growth in the coming years.

At Evergreen, we foster a collaborative environment where all team members contribute to various tasks. We seek individuals who are eager to embrace new challenges and are enthusiastic about playing a role in the company's development. Partial equity-based compensation packages may be available.

Key Responsibilities

  • Ensure adherence to Health Authority (e.g., FDA/EMA) regulations for NDA/MAA/IND or CTA interactions.
  • Oversee regulatory activities for multiple projects concurrently and adapt swiftly to evolving circumstances and priorities.
  • Assist in formulating regulatory strategies and revise them in response to regulatory updates.
  • Facilitate the preparation and development of submission documents for health authorities, ranging from early-phase clinical submissions to marketing applications and lifecycle management.
  • Supervise and evaluate recommendations and the implementation of enhancements driven by new regulations, agency guidance, industry standards, technological advancements, and internal requirements.
  • Stay informed about scientific and industry developments and integrate relevant insights into work processes.
  • Ensure readiness for inspections.
  • Draft/review/approve standard operating procedures, batch records, specifications, validation protocols and reports, and instrument acquisitions/decommissions, as necessary.
  • Support all global Health Authority submission activities (planning, drafting, reviewing, coordinating, submitting) for projects/products, while applying a global strategy to submissions.
  • Guarantee the timely completion, accuracy, and quality of all regulatory and submission documentation throughout the product lifecycle.
  • Enhance the regulatory documentation process and provide strategic direction and best practices.
  • Identify necessary documentation and any content, quality, and/or timeline challenges for global submissions; negotiate the delivery of approved technical source documents in line with project timelines.
  • Effectively translate scientific data into clear, well-organized, scientifically sound regulatory documents intended for global health authorities and stakeholders.

Qualifications and Education

  • 5+ years of regulatory experience within the pharmaceutical industry.
  • Experience with direct interactions with FDA and EMA.
  • A minimum of a bachelor's degree; an advanced scientific degree is preferred.
  • Familiarity with radiopharmaceuticals is advantageous.
  • Exceptional communication abilities.
  • Strong technical writing proficiency.
  • Self-motivated individual with robust problem-solving capabilities.