Strategic Regulatory Leader — Remote

Parexel; Montgomery (AL); Remote; USD 190,000 - 230,000; Full time

Benefits offered by this job

Health, Vision & Dental 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 in a remote capacity. You will own regulatory strategy across major programs, provide leadership for regulatory decisions, and guide submissions.

This role emphasizes lifecycle planning, authority engagement, and cross-functional collaboration with biopharmaceutical partners to shape regulatory pathways. You will contribute to long-range development plans, work with diverse teams, and influence development timelines to drive

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field or equivalent experience.
• 10+ years in regulatory affairs or clinical development.
• Vaccine/biologic product experience required.
• Deep knowledge of ICH-GCP, FDA, and international regulations.
• Experience with regulatory tracking systems and submission tools.

Responsibilities

• Lead regulatory strategy across programs to align with objectives.
• Provide leadership on authority engagement and submission strategies.
• Manage high-impact regulatory submissions with cross-functional teams.
• Develop long-range development and lifecycle plans for regulatory pathways.
• Collaborate with clinical, scientific, and commercial teams to align timelines.

Skills

Regulatory strategy

Cross-functional leadership

Clinical development experience

Regulatory affairs

Strategic planning

Communication

Problem-solving

Regulatory databases

Submission management

Education

Bachelor's degree in life sciences/related field

Advanced degree preferred (MD/PhD/MBA)

Tools

Regulatory tracking systems

Electronic submission tools

Clinical development platforms

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team in a remote capacity. You will own regulatory strategy across major programs, provide leadership for regulatory decisions, and guide submissions.

This role emphasizes lifecycle planning, authority engagement, and cross-functional collaboration with biopharmaceutical partners to shape regulatory pathways. You will contribute to long-range development plans, work with diverse teams, and influence development timelines to drive