Director of Regulatory Affairs

Director of Regulatory Affairs

As the Director of Regulatory Affairs, you will be at the helm of steering regulatory strategies and submissions to ensure the advancement and commercial success of our pharmaceutical products. Your leadership will be pivotal in collaborating with cross-functional teams to navigate the complexities of drug approvals in both the U.S. and global markets. This role demands a proactive approach to define and implement innovative regulatory pathways that favorably impact all stakeholders, from product concept to market launch.

Salary: DOE per year

Essential Duties and Responsibilities:

• Lead regulatory strategies and manage submissions in alignment with corporate goals.
• Partner with departments such as R&D, Technical Operations, Clinical Development, and others to move the drug portfolio forward.
• Ensure compliance with U.S. and international regulatory requirements throughout the product lifecycle.
• Develop strategic initiatives to introduce new regulatory pathways enhancing stakeholder benefits.
• Guide the development programs to align with regulatory standards and achieve approval for market launch.

Minimum Position Qualifications:

• 7–12 years of regulatory experience in the pharmaceutical or biopharmaceutical industry.
• Demonstrated leadership in regulatory roles with a focus on 505(b)(1), 505(b)(2), and 505(j) submissions.
• Proven success in filing and achieving FDA and international regulatory approvals.
• Robust knowledge in all phases of drug development including CMC, preclinical, clinical and post-marketing.
• Effective communicator with a history of productive interactions with the FDA and other regulatory bodies.

Preferred Qualifications:

• Advanced degree in a scientific or related field.
• Comprehensive understanding of global healthcare environments influencing regulatory framework.
• Strategic thinker with the ability to anticipate changes in regulatory guidelines.
• Previous experience in oncology, rare diseases, or chronic conditions preferred.
• Comfortable working in fast-paced, dynamic environments.

Skills:

• Strong leadership and management abilities.
• Excellent strategic planning and organizational skills.
• High proficiency in written and verbal communication.
• Ability to handle multiple projects and deadlines.
• Detail-oriented with a critical approach to problem-solving.

Benefits:

• Competitive salary and benefits package including healthcare, dental, and vision.
• Generous paid time off and flexible working arrangements.
• Opportunities for continuous learning and career advancement.
• Annual performance-based bonuses.
• Retirement plan with company matching.