Senior Director Regulatory Affairs

Job Title: Senior Director, Regulatory Affairs

Location: Remote / Hybrid

Employment Type: Full-Time, Permanent

Job Description

Stirling Q&R is looking for an experienced and strategic Senior Director of Regulatory Affairs to lead the regulatory strategy and operations for our esteemed client in the biotech industry. This key leadership position requires an in-depth understanding of regulatory pathways, efficient management of regulatory processes, and the ability to navigate complex regulatory environments.

Responsibilities

• Develop and implement regulatory strategies to support product development and market access for biopharmaceutical products.
• Lead a team of regulatory professionals to ensure the timely preparation and submission of high-quality regulatory documentation to health authorities, including INDs, BLAs, and MAAs.
• Advise cross-functional teams on regulatory requirements and provide guidance on compliance during research and development stages.
• Establish and maintain relationships with regulatory agencies and act as the primary point of contact during agency interactions.
• Monitor and assess changes in regulations and guidelines to provide strategic insights to the team and company leadership.
• Oversee the preparation for regulatory submissions and inspections, ensuring adherence to best practices.
• Mentor and develop regulatory staff, fostering a culture of excellence and accountability.

Qualifications

• Advanced degree (PhD, MS, or equivalent) in a relevant scientific field.
• 8-10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industries, with at least 5 years in a leadership role.
• Deep understanding of regulatory requirements for product development, submissions, and compliance protocols.
• Proven track record of successful submissions and approvals with health authorities (e.g., FDA, EMA).
• Strong leadership and team management skills with the ability to inspire and guide diverse teams.
• Excellent communication, negotiation, and organizational skills.
• Strategic thinker with the ability to make high-level decisions and steer the direction of regulatory activities.

Benefits

• Private Health Insurance
• Pension Plan
• Work From Home