Regulatory Affairs Consultant, CMC – Biologics

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

📋 Description

• Assist Regulatory Affairs leaders in crafting CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products.

• Aid in the development of CMC regulatory strategies for products in the development phase, spanning from early development to marketing applications and post-approval modifications.

• Identify regulatory, scientific, and technical prerequisites for CMC and GMP-related submissions and inquiries.

• Prepare, coordinate, and review CMC and GMP-related documents intended for submission to regulatory authorities.

• Represent CMC Regulatory Affairs during project team meetings and offer regulatory guidance to cross-functional teams.

• Assist in the preparation for health authority CMC meetings, including mock meetings and meeting planning.

• Contribute to monthly CMC GRT meetings alongside global cross-functional teams.

• Collaborate with manufacturing and quality teams, partner organizations, and other stakeholders on CMC matters.

• Foster and maintain collaborative relationships with CMC Regulatory Affairs, manufacturing sites, Quality, Technical Operations, affiliates, external partners, contract manufacturers, packagers, and suppliers.

• Draft departmental job procedures.

• Evaluate and develop innovative strategies to enhance CMC Regulatory Affairs departmental processes, boost efficiencies, and tackle current and future challenges.

• Provide insights and expertise on CMC regulatory strategies for investigational, new, and marketed biologic and small molecule drug products.

• Ensure compliance with global regulatory requirements and guidelines, with a primary focus on the US, EU, and Canada.

⛳️ Requirements

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.

• 4-6 years of CMC experience within the pharmaceutical industry, with a proven track record of successfully preparing regulatory filing documentation.

• In-depth knowledge of the drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and associated issues.

• Familiarity with CMC regulatory requirements for biologics and small molecules throughout development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products.

• Extensive experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for the FDA, as well as equivalent submissions for Europe and Canada.

• Thorough understanding of the global regulatory landscape.

• Proven proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

• Strong analytical, problem-solving, organizational, and negotiation capabilities.

• Skills in proactive strategic thinking, analytical problem-solving, and negotiation.

• Experience in the pharmaceutical industry within a regulated environment.

• Excellent collaborative, communication, and presentation skills, with the capability to lead meetings and work effectively in a matrixed setting and across cultural boundaries.

• Competence in preparing high-quality technical documents and submissions using internal systems.

• Ability to independently manage and prioritize a multi-project workload.

• Familiarity with document management and regulatory information systems, including Trackwise Digital and TRS Viewer.

• Preferred: Master's or Ph.D. degree, ideally in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology.

• Preferred: Regulatory Affairs Certification (RAC).

• Preferred: Experience with CPP application filing through eCATS and 510(j)(3) reporting via nextGen portals.

🏝️ 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.

• Some roles may also qualify for additional incentives, bonuses, or other compensation programs.