Global Regulatory Strategy Lead — Marketed Products

SoTalent; Boston (MA); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Highly competitive compensation package

Bonus potential

Excellent healthcare and retirement benefits

Generous paid time off

Ongoing professional development opportunities

Job summary

SoTalent is seeking an Associate Director, Global Regulatory Affairs to influence global regulatory strategy for innovative therapies. This role is critical in shaping regulatory strategies and ensuring successful outcomes with cross-functional teams.

The successful candidate will have significant experience in Regulatory Affairs, strong leadership skills, and proven interactions with the FDA. You'll benefit from a competitive compensation package, bonus potential, and excellent healthcare benefits.

Qualifications

• Significant pharmaceutical industry experience with a strong background in Regulatory Affairs.
• Proven experience developing and executing global regulatory strategies.
• Experience leading regulatory submissions and interactions with major health authorities, particularly the FDA.

Responsibilities

• Leading global regulatory strategies across complex product portfolios.
• Managing regulatory submissions, approvals, and lifecycle management activities.
• Serving as the primary contact for regulatory authorities, including direct interaction with the FDA.

Skills

Regulatory Affairs

Stakeholder management

Leadership

Communication skills

Regulatory strategy development

Job description

SoTalent is seeking an Associate Director, Global Regulatory Affairs to influence global regulatory strategy for innovative therapies. This role is critical in shaping regulatory strategies and ensuring successful outcomes with cross-functional teams.

The successful candidate will have significant experience in Regulatory Affairs, strong leadership skills, and proven interactions with the FDA. You'll benefit from a competitive compensation package, bonus potential, and excellent healthcare benefits.