Regulatory Affairs Strategy Consultant

Candidate would provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.

This individual will be responsible for assuring the CMC regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality.

Responsibilities Include, But Are Not Limited To

• As a member of CMC project teams, provide strategic CMC regulatory leadership support for designated CGT programs.
• Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs).
• Primary regulatory representative (for assigned projects) at internal and Sponsor meetings as well as at meetings with regulatory agencies for CMC related issues.
• Lead negotiations with regulatory agencies to resolve CMC issues and oversee proactive interactions with regulators globally (US, EU and Japan) for initial INDs/CTAs, marketing registration applications, supplements and variations.
• Assess and communicate regulatory requirements to ensure all development activities comply with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Responsible for compilation, review, approval and submission of high-quality CMC related sections of INDs/CTAs, including responses to questions from various regulatory authorities, working in collaboration with SME’s in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners. Maintain responsibility for all CMC Regulatory timelines.
• Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
• Other duties as assigned.

Position Requirements & Experience

• Advanced scientific degree preferred in the sciences, or health related field or equivalent experience.
• CMC regulatory experience in the pharmaceutical/biotech industry
• Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the areas of Cell and Gene Therapy
• Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline)Regulatory experience supporting both development projects and marketed products including support of post-approval dossier life cycle management.
• Experience with Orphan Drug Designation, BTD, RMAT, direct interactions supporting health authority GMP inspections desirable is preferred.
• Strong knowledge of eCTD elements and structure including CMC-regulatory writing skills
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team and drive results.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.