Remote Regulatory Strategy Leader - Global Submissions

Parexel; Augusta (ME); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel seeks a Regulatory Strategy Consultant to lead regulatory strategy across major programs, influencing authority engagement and submission approaches. This role emphasizes lifecycle management and cross-functional collaboration to streamline development and regulatory pathways.

The ideal candidate has 10+ years in regulatory affairs, with vaccine/biologic product exposure, and extensive knowledge of global regulatory requirements.

Qualifications

• Bachelor's degree and 10+ years in regulatory affairs or related field.
• Previous vaccine/biologic regulatory experience is required.
• Deep knowledge of ICH-GCP, FDA and international regulatory requirements.

Responsibilities

• Own and regulate regulatory strategy across significant programs or portfolios.
• Provide leadership on major regulatory decisions and submission strategies.
• Lead planning and execution of high-impact regulatory submissions.
• Develop long-range development and lifecycle management plans.
• Collaborate with clinical, scientific, and commercial teams to align strategy with timelines.
• Monitor regulatory landscape changes and advise adaptation strategies.

Skills

Regulatory strategy

Strategic planning

Cross-functional leadership

Clinical development experience

Regulatory affairs

Communication skills

Attention to detail

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

Regulatory databases

Submission management systems

Job description

Parexel seeks a Regulatory Strategy Consultant to lead regulatory strategy across major programs, influencing authority engagement and submission approaches. This role emphasizes lifecycle management and cross-functional collaboration to streamline development and regulatory pathways.

The ideal candidate has 10+ years in regulatory affairs, with vaccine/biologic product exposure, and extensive knowledge of global regulatory requirements.