Principal Regulatory Affairs Consultant

About the role

As a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. You will serve as a strategic partner, leveraging your expertise to navigate regulatory requirements and optimize pathways for drug submissions.

Responsibilities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients.
• Handle FDA Type A, Type B, and Type C meetings.
• Engage in all phases of drug development, from early-stage to post-registration.
• Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams.
• Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality.
• Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines.
• Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements.
• Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement.
• Serve as the main point of contact for clients, ensuring effective communication and regulatory support.
• Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes.
• Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions.
• Partner with clients on Non-Clinical/Clinical strategy and submissions.
• Evaluate proposed manufacturing and quality changes for impact on existing registrations.
• Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.

Requirements

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred.
• RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued.

Essential Functions

• Strong background in drug development, biologics, and clinical trials.
• Proven experience in handling INDs, NDAs, BLAs, and global submissions.
• Demonstrated ability to adapt to client needs, providing strategic advice and tactical support across various therapeutic areas.
• Attended relevant conferences, training, and job shadowing opportunities.
• Proficient in Microsoft Office Suite and industry-specific software tools such as Trackwise, Veeva, and ICTD.
• Strong understanding of drug development, manufacturing, and clinical development processes.
• Experience in authoring and managing Non-Clinical/Clinical Medical Device and FDA sections for regulatory submissions.
• Ability to evaluate manufacturing and quality changes for regulatory impact.
• Demonstrated proficiency in regulatory information management systems and tools.