Remote Regulatory Strategy Leader

Parexel; Columbia (SC); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation time

401(k) with company match

Work/Life Balance

Pet Insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across significant programs in a remote capacity. You will drive major submissions, engage with authorities, and guide lifecycle planning, working with biopharmaceutical partners to shape regulatory pathways.

The role emphasizes strategic leadership, cross-functional collaboration, and staying ahead of regulatory landscape changes to optimize development timelines and commercial outcomes.

Qualifications

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

Responsibilities

• Lead regulatory strategy across major programs and portfolios.
• Direct authority engagement models and submission strategies.
• Coordinate high-impact regulatory submissions with cross-functional teams.
• Develop long-range development and lifecycle plans.
• Collaborate with clinical, scientific, and commercial teams on timelines.

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Regulatory communications

Problem solving

Education

Bachelor's degree in life sciences or related field

Tools

Regulatory tracking systems

Electronic submission tools

Job description

Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across significant programs in a remote capacity. You will drive major submissions, engage with authorities, and guide lifecycle planning, working with biopharmaceutical partners to shape regulatory pathways.

The role emphasizes strategic leadership, cross-functional collaboration, and staying ahead of regulatory landscape changes to optimize development timelines and commercial outcomes.