Regulatory Affairs Consultant – CMC Biologics, Plasma Products

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.

• Evaluate change controls and deliver regulatory evaluations of quality alterations in production and quality control processes.

• Examine study reports and quality documentation from manufacturing and quality control sectors to ensure adherence to regulatory standards.

• Coordinate the preparation of submissions with manufacturing, supply chain, quality control, quality assurance, and other regulatory teams.

• Draft and review submission materials concerning variations and responses to inquiries from health authorities.

• Oversee projects within Regulatory Information Management systems, ensuring the accuracy and upkeep of global submissions.

• Recognize, escalate, and manage risks related to regulatory procedures and activities across international markets.

• Assist in post-approval regulatory functions and contribute to regulatory operations from submission planning to approval and market expansion.

• Collaborate with cross-functional teams, including manufacturing, quality, and supply chain partners.

⛳️ Requirements

• Bachelor’s degree in Chemistry or a related field within Life Sciences.

• Over 5 years of experience in regulatory affairs, specifically in technical/CMC/quality regulatory roles in the pharmaceutical sector.

• Comprehensive knowledge of CMC and post-approval regulatory requirements for global markets including the US, EU, CA, CH, AU, CN, and BR.

• Proven experience in drafting CMC (technical) sections of regulatory documents such as registration files or variations.

• Prior experience in biologics regulatory CMC.

• Proficiency in CMC regulatory strategy, post-approval regulatory processes, and quality/technical documentation.

• Experience in regulatory affairs, pharmaceutical quality, or a highly regulated setting.

• Capability to work collaboratively across teams and communicate effectively with internal stakeholders and regulatory bodies.

• Detail-oriented with a quality-focused mindset regarding regulatory documentation and compliance.

• Familiarity with regulatory information management systems, as well as proficiency in Word, PowerPoint, and Excel.

• Strong skills in communication, organization, and problem-solving.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.

• Flexible work arrangements.

• Potential eligibility for additional incentives, bonuses, or other compensation programs.