Remote Regulatory Strategy Leader

Parexel; Concord (NH); Remote; USD 160,000 - 230,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation time

401(k) with company match

Life insurance

Job summary

Parexel is seeking a Regulatory Strategy Consultant to join our team remotely. You will own regulatory strategy across major programs, guiding submissions and authority engagement, while shaping long-range development plans.

You’ll lead cross-functional teams to align regulatory objectives with business goals and drive lifecycle management. The role emphasizes strategic regulatory leadership in a fast-paced environment with learning opportunities across therapeutic areas.

Qualifications

• Bachelor’s degree or equivalent in life sciences or related field.
• 10+ years in regulatory affairs or clinical development.
• Vaccine/biologic regulatory experience required.
• Knowledge of ICH-GCP and FDA/regional requirements.
• Experience with submission tracking systems and e-submission platforms.

Responsibilities

• Lead regulatory strategy across programs and portfolios.
• Direct authority engagement models and submission strategies.
• Manage high-impact regulatory submissions and timelines.
• Develop long-range development and lifecycle plans.
• Collaborate across clinical, scientific, and commercial teams.
• Monitor regulatory changes and advise on strategy.

Skills

Regulatory strategy

Cross-functional leadership

Clinical development

Regulatory submissions

Education

Bachelor's degree in life sciences/pharmacy/medicine

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

Tools

Regulatory tracking systems

Electronic submission tools

Job description

Parexel is seeking a Regulatory Strategy Consultant to join our team remotely. You will own regulatory strategy across major programs, guiding submissions and authority engagement, while shaping long-range development plans.

You’ll lead cross-functional teams to align regulatory objectives with business goals and drive lifecycle management. The role emphasizes strategic regulatory leadership in a fast-paced environment with learning opportunities across therapeutic areas.