Senior Regulatory Affairs Consultant – CMC Biologics

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

📋 Description

• Assist regulatory leads in formulating CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products.

• Identify regulatory and scientific/technical requirements for CMC and GMP-related submissions and inquiries.

• Represent CMC regulatory affairs in project team meetings and offer regulatory guidance and insights to cross-functional teams alongside global regulatory leads.

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

• Develop CMC regulatory strategies for products in the developmental phase, from early development to marketing applications.

• Assist with post-approval changes for products that are already marketed.

• Collaborate with manufacturing, quality, and partner organizations to address CMC-related concerns and ensure alignment.

• Build and sustain relationships with local and global functional units, manufacturing sites, contract manufacturers, and external partners.

• Aid in the preparation for health authority CMC meetings and conduct mock meetings.

• Evaluate and generate ideas to enhance CMC regulatory departmental processes and boost efficiencies.

• Support regulatory strategy and compliance for drug development across investigational, new, and marketed products.

• Work in partnership with manufacturing, quality, and project management teams.

• Contribute to product development from initial stages through to post-approval.

⛳️ Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).

• At least 7 years of CMC experience in the pharmaceutical industry with a proven track record in successful regulatory filing documentation.

• In-depth knowledge of drug development processes, pharmaceutical technology, drug manufacturing processes, and GMP requirements.

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

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

• Comprehensive understanding of the global regulatory landscape.

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

• Excellent collaborative, interpersonal, communication, and presentation skills.

• Proven ability to work independently, manage multiple projects, and prioritize tasks in a matrixed environment.

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

• Experience in pharmaceutical development, regulatory affairs, or a highly regulated environment.

• Comfortable working with regulatory information systems, document management platforms, and Microsoft Office applications.

🏝️ 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.

• Additional benefit offerings in accordance with applicable plans.

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