Regulatory Strategy Consultant

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

📋 Description

• Take ownership of and enhance regulatory strategies for key programs or portfolios, ensuring they align with business goals and regulatory standards.

• Provide guidance on critical regulatory decisions, including engagement models with authorities, submission strategies, and approaches to risk mitigation.

• Lead the organization and implementation of significant regulatory submissions, coordinating with cross-functional teams to ensure adherence to regulatory requirements.

• Create and execute long-term development and lifecycle management plans that maximize regulatory pathways and commercial results.

• Collaborate with clinical, scientific, and commercial teams to synchronize regulatory strategies with development schedules and market prospects.

• Keep track of changes in the regulatory landscape and offer strategic insights to modify development and submission tactics accordingly.

• Influence regulatory pathways and steer long-term development strategies in partnership with biopharmaceutical entities.

• Propel submissions that introduce new therapies to patients.

• Play a role in long-term development and lifecycle planning.

⛳️ Requirements

• 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 similar domain.

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

• Comprehensive understanding of ICH-GCP, FDA, international regulatory requirements, and clinical trial processes.

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

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

• Expertise in regulatory strategy, strategic planning, and cross-functional leadership.

• Extensive background in clinical development, regulatory affairs, or within a highly regulated setting.

• Capability to lead across teams, influence stakeholders, and clearly articulate complex regulatory concepts.

• Patient-centric mindset with a keen focus on regulatory accuracy and compliance.

• Comfortable working with regulatory databases, submission management systems, and collaborative platforms.

• An advanced degree or regulatory certification is preferred.

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

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

• Proficiency 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

• Flexible work arrangements

• Continuous learning opportunities

• Career paths and opportunities to expand expertise across therapeutic areas and development phases

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