Director of Regulatory Operations and Strategy

Position Overview: We are seeking a highly experienced and strategic Director of Regulatory Operations and Strategy to lead our regulatory team and drive the successful development and approval of our therapeutic candidates. This role is crucial in ensuring that the pharmaceutical remains at the forefront of regulatory compliance and strategy, navigating complex regulatory environments to advance our product pipeline.
Key Responsibilities:

• Regulatory Strategy Development:
• Develop and implement comprehensive regulatory strategies to support the development and commercialization of products.
• Lead strategic planning sessions for regulatory submissions, including INDs, NDAs, BLAs, and other regulatory filings.
• Provide expert guidance on regulatory requirements and expectations for new and ongoing projects.
• Regulatory Operations Management:
• Oversee day-to-day regulatory operations, including the preparation, submission, and management of regulatory documents and applications.
• Ensure timely and effective responses to regulatory queries and inspections.
• Manage relationships with regulatory agencies and coordinate meetings and interactions with FDA, EMA, and other regulatory bodies.
• Cross-Functional Collaboration:
• Collaborate closely with R&D, clinical development, manufacturing, and commercial teams to ensure regulatory requirements are integrated into project plans and timelines.
• Provide regulatory expertise and support for clinical trial design, product labeling, and market access strategies.
• Regulatory Intelligence:
• Stay abreast of regulatory changes and industry trends, and assess their potential impact on the company’s operations and strategy.
• Implement best practices and processes to enhance regulatory efficiency and effectiveness.
• Compliance and Quality Assurance:
• Ensure compliance with regulatory requirements and internal policies, maintaining the highest standards of quality and integrity.
• Oversee the development and implementation of regulatory training programs for staff.

Qualifications:

• Education:
• Advanced degree in a relevant scientific discipline (e.g., PhD, PharmD, MS) is preferred.
• Experience:
• Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on drug development and regulatory strategy.
• Experience in Infectious Diseases is a must
• Proven track record of successful regulatory submissions and interactions with regulatory agencies.
• Extensive experience managing and leading regulatory operations and teams.
• Skills:
• Strong understanding of regulatory requirements, guidelines, and processes for drug development and approval.
• Excellent strategic thinking, problem-solving, and decision-making skills.
• Outstanding communication and interpersonal skills, with the ability to influence and collaborate effectively across functions and with external stakeholders.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.

Desire to both set the strategy and operationalize it

Posted On: Monday, November 11, 2024