Senior Director of Regulatory Writing - Remote

About the Role

We are seeking a Senior Director of Regulatory Writing - Remote to lead our regulatory writing team in the biotechnology sector. This role is pivotal in ensuring that our regulatory documents meet the highest standards and comply with all relevant guidelines. As a Senior Director, you will have the opportunity to shape regulatory strategies and work closely with cross-functional teams to drive our clinical research initiatives forward.

What You'll Do

• Lead the regulatory writing team, overseeing the preparation of regulatory submissions including INDs, CTAs, and other documents required by health authorities.
• Ensure compliance with FDA, EMA, and PMDA regulations, as well as ICH guidelines.
• Collaborate with clinical research teams to develop clear and concise clinical trial protocols and reports.
• Provide strategic regulatory guidance and support to internal stakeholders and external partners.
• Manage the submission process and liaise with health authorities to facilitate timely approvals.
• Conduct training sessions for team members on regulatory writing best practices and compliance requirements.
• Stay updated on regulatory changes and trends in the biotechnology and pharmaceutical industries.
• Foster a culture of excellence and continuous improvement within the regulatory writing team.

Requirements

• Minimum of 8 years of experience in regulatory writing within the biotechnology or pharmaceutical industry.
• Proven track record of successful regulatory submissions to health authorities.
• Strong understanding of regulatory compliance and quality assurance processes.
• Excellent written and verbal communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional environment.
• Experience in managing teams and mentoring junior staff.
• Advanced degree in life sciences, regulatory affairs, or a related field is preferred.

Nice to Have

• Experience with medical devices and FDA submissions.
• Knowledge of ECTD structure and submission processes.
• Familiarity with global regulatory strategies and health authorities liaison.

What We Offer

• Competitive salary and bonus structure.
• Comprehensive health and welfare benefit plans.
• Non-accrual paid time off and company shutdown for holidays.
• 401K match and daily lunch provided.
• Flexible remote work environment with a focus on work-life balance.