Director, CMC Regulatory Affairs

About the role

Vir Biotechnology, Inc. is seeking a Director of Regulatory CMC to ensure all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. The role requires a track record of successful regulatory submissions and a passion to challenge conventional paradigms.

Responsibilities

• Provide strategic CMC regulatory leadership to develop and execute sound regulatory strategies that meet global regulatory requirements and enable Vir business objectives
• Provide CMC regulatory expertise to enable global development and registration for INDs, CTAs, BLAs and MAAs
• Identify and communicate regulatory risks and facilitate the development and execution of risk mitigation strategies in concert with Technical Operation functions
• Plan strategy for and lead HA interactions for CMC specific issues
• Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable)
• Ensure overall dossier compliance with regulatory requirements
• Ensure compliance with internal SOP's and policies
• Contribute to regulatory excellence by identifying opportunities and supporting continuous improvement

Requirements

• B.S., M.S., Ph.D. or other relevant advanced degree or certificate
• 10+ years experience in pharmaceutical product development including strong global Regulatory CMC leadership
• Regulatory CMC experience leading both development projects (IND/CTA) and initial registration (BLA/MAA)
• Experience with CMC regulatory considerations for late stage and/or commercial large molecules (biologics)
• Experience with combination product or oligonucleotide experience is a plus
• Preference will be given to candidates with recent experience with initial BLA and/or NDA (CMC sections)
• Management of US post-market, biologic product CMC changes is a plus
• Experience with Health Authority interactions is desirable
• Thorough understanding of major FDA, EMA, ICH, EudraLex CMC guidelines
• Global clinical filing experience (US, EU, UK, CA)
• Working knowledge of other global clinical territories procedures a plus
• Ability to effectively present to Senior Management

Qualifications

• Strong communication and interpersonal skills
• Proven ability to manage multiple projects simultaneously
• Excellent problem-solving and analytical skills
• Ability to work independently and as part of a team
• Strong organizational and time management skills

Skills

• Strong understanding of CMC regulatory guidelines and processes
• Experience with regulatory submissions and approvals
• Knowledge of biologics and combination products
• Experience with Health Authority interactions
• Strong leadership and mentoring skills

Benefits

The expected salary range for this position is $195,500 to $272,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Vir Biotechnology offers a competitive compensation and benefits package, including:

• Compensation, bonus, and equity
• Non-accrual paid time off
• Company shut down for holidays
• Commuter benefits
• 401K match
• Lunch each day in the office