Regulatory Affairs Associate II

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Regulatory Affairs Associate II
Location: Lake County, IL
Duration: Long Term

Job Overview

We are seeking a Regulatory Affairs Associate II to manage and compile Chemistry, Manufacturing, and Controls (CMC) sections for marketed product variations. The role involves preparing regulatory dossiers, developing CTD Module 3 content, coordinating cross-functional teams, and ensuring accurate and timely regulatory submissions in compliance with applicable requirements.

Key Responsibilities

• Author, manage, and compile CMC sections for marketed product variations.
• Prepare and review CTD Module 3 content, ensuring structural, formatting, and documentation requirements are met.
• Develop project timelines and coordinate submission activities with Regulatory Affairs CMC Project Leads.
• Manage assigned regulatory projects to ensure accurate, complete, and timely dossiers and responses.
• Facilitate project meetings and coordinate activities across Regulatory Affairs, R&D, Manufacturing, and other functional teams.
• Review regulatory documents for accuracy, completeness, and submission readiness.
• Maintain familiarity with US and international regulatory requirements and current regulatory best practices.
• Use electronic document management systems and regulatory business tools.
• Manage multiple projects independently while adapting to changing priorities and project requirements.

Required Qualifications

• Bachelor's degree in Chemistry, Biological Sciences, or a related discipline.
• Minimum 4 years of pharmaceutical industry experience.
• 1 2 years of cross-functional project management experience.
• Experience authoring and compiling CMC regulatory submissions for marketed product variations.
• Knowledge of CTD structure, particularly Module 3, and regulatory dossier requirements.
• Familiarity with US and international regulatory requirements.
• Experience with electronic document management systems.
• Strong project coordination, meeting facilitation, written communication, and organizational skills.
• Ability to manage multiple projects independently with strong attention to detail.
• Experience in Regulatory Affairs, R&D, or Manufacturing is preferred.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.