Mediabistro is hiring: Director, Regulatory Affairs and Medical Writing in San D

Overview

Director, Regulatory Affairs and Medical Writing

We are seeking an experienced and highly motivated Director of Regulatory Affairs, Medical Writing, and Quality Assurance to lead our regulatory strategy, medical writing initiatives, and quality assurance processes. This pivotal role requires a deep understanding of regulatory environments, exceptional leadership skills, and a passion for ensuring the highest standards of quality in our deliverables.

Responsibilities

• Develop and implement regulatory strategies for product development, ensuring compliance with global regulatory requirements.
• Oversee all aspects of medical writing, including the preparation of clinical study protocols, clinical study reports, and regulatory submissions, ensuring clarity, accuracy, and adherence to regulatory guidelines.
• Lead the Quality Assurance (QA) team to establish and maintain a robust quality management system that complies with applicable regulations and standards.
• Collaborate cross-functionally with R&D, clinical operations, and commercial teams to align regulatory and quality objectives with company priorities.
• Stay current with changes in regulatory requirements and industry best practices; assess their impact on ongoing and future projects.
• Provide regulatory guidance to project teams and facilitate effective communication with regulatory agencies.
• Mentor and develop the regulatory, medical writing, and QA teams, fostering a culture of excellence, accountability, and continuous improvement.
• Manage audits and inspections, ensuring preparedness and compliance with regulatory standards.

Qualifications

• Bachelor’s degree in a relevant scientific discipline; advanced degree (e.g., Master’s, PhD) preferred.
• 5+ years of experience in regulatory affairs, medical writing, and quality assurance within the pharmaceutical or biotechnology industry.
• Proven track record of successfully navigating complex regulatory landscapes and leading successful submissions to regulatory agencies (e.g., FDA, EMA).
• Strong understanding of GxP regulations and quality management systems.
• Exceptional written and verbal communication skills, with a strong attention to detail.
• Demonstrated leadership and teamwork abilities with a focus on mentorship and development.
• Ability to manage multiple projects simultaneously and work effectively in a fast-paced environment.

Why Join Us?

• Award-winning CRO and Functional Service Provider
• Selected in the Best Places to Work
• Competitive salary and comprehensive benefits package
• Opportunities for professional growth and development
• Collaborative and innovative work environment
• Commitment to making a difference in patients’ lives