Director, Regulatory Affairs

The Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle. This role is accountable for the development and filing strategies for CMC modules/updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications, and other regulatory documentation (GMO, briefing documents, responses to IRs, etc.) for assigned products. This role provides regulatory guidance to various cross-functional teams on CMC regulatory strategy to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development strategy of the assigned products. This role will be a key interface between CMC subject matter experts (SMEs) and Global Regulatory Affairs.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products
• Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success and timelines, exercising sound judgement, and communicating in a professional and timely manner.
• Effectively communicate regulatory CMC strategy, risks, mitigations, and overall plans to project team, regulatory leadership team, and key stakeholders, as relevant.
• Actively collaborates with internal and external teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies
• Plans, executes, and manages regulatory CMC submissions including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, responses to CMC Information Requests, etc.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)
• Perform life cycle management for marketed products on a global basis, including regulatory impact assessments and preparation of CMC documentation for variations and other post marketing submissions
• Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions
• Evaluates change proposals for global regulatory impact and plans global amendments
• Assess change controls and provide assessment of regulatory impact

QUALIFICATIONS:

• Bachelor's Degree in a scientific discipline is required; advanced degree is preferred.
• Minimum of 10 years of relevant pharmaceutical/biotech experience including 5 years of Global Regulatory Affairs CMC experience
• Experience in cell/gene therapy
• Experience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process development
• Proven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.
• Successful track record of providing robust regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
• Experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)
• Ability to effectively liaise with Regulatory Agencies, having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferred
• Knowledge of relevant domestic and global regulations and guidance
• Ability to work effectively in cross-functional teams

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet.

Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.