Regulatory Strategy Consultant

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

📋 Description

• Take ownership and develop the regulatory strategy for significant programs or portfolios.

• Provide leadership on key regulatory decisions, authority engagement models, submission strategies, and approaches for risk mitigation.

• Lead the planning and execution of impactful regulatory submissions.

• Coordinate with cross-functional teams to ensure adherence to regulatory requirements.

• Develop and execute long-term development and lifecycle management plans.

• Collaborate effectively with clinical, scientific, and commercial teams.

• Monitor changes in the regulatory landscape and offer strategic recommendations.

• Shape regulatory pathways and direct long-term development strategies for biopharmaceutical partners.

⛳️ Requirements

• A Bachelor's degree in life sciences, pharmacy, medicine, or a related field, or equivalent professional experience.

• Over 10 years of experience in regulatory affairs, clinical development, or a related field.

• Prior experience with vaccine and/or biologic products is essential.

• Extensive knowledge of ICH-GCP, FDA and international regulatory requirements, and clinical trial processes.

• Proficiency in regulatory tracking systems, electronic submission tools, and clinical development platforms.

• Exceptional communication, strategic planning, and problem-solving skills, along with proven leadership capabilities.

• An advanced degree (M.D., Ph.D., or M.B.A.) or a regulatory certification (e.g., RAC) is preferred.

• Experience across multiple therapeutic areas or development phases is preferred.

• Familiarity with global regulatory frameworks and international submission strategies is preferred.

• Fluency in additional languages pertinent to regulatory submissions is preferred.

🏝️ 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.

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