Remote Regulatory Strategy Lead for Global Programs

Parexel; Baton Rouge (LA); Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to join our team remotely. You will own regulatory strategy across major programs, guiding authority engagement and high-impact submissions.

The role emphasizes lifecycle planning, cross-functional leadership, and strategic regulatory thinking to accelerate clinical development. You will collaborate with biopharmaceutical partners and diverse teams, shaping pathways and development strategies while ensuring compliance with global regulatory

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• 10+ years in regulatory affairs, clinical development, or related field.
• Experience with vaccine and/or biologic products is required.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements.
• Experience with regulatory tracking systems, electronic submission tools, and clinical development platforms.

Responsibilities

• Own regulatory strategy across significant programs or portfolios with cross-functional alignment.
• Provide leadership on authority engagement models and submission strategies.
• Lead planning and execution of high-impact regulatory submissions with teams.
• Develop long-range development and lifecycle plans to optimize regulatory pathways.
• Collaborate with clinical, scientific, and commercial teams to align timelines.
• Monitor regulatory landscape changes and adapt development and submission approaches.

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Communication skills

Regulatory databases

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred (M.D./Ph.D./MBA) or RAC

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team remotely. You will own regulatory strategy across major programs, guiding authority engagement and high-impact submissions.

The role emphasizes lifecycle planning, cross-functional leadership, and strategic regulatory thinking to accelerate clinical development. You will collaborate with biopharmaceutical partners and diverse teams, shaping pathways and development strategies while ensuring compliance with global regulatory