Director/Senior Director, Regulatory CMC

The Director/Senior Director, Regulatory CMC will be responsible for regulatory CMC leadership across all development programs leading to successful preparation of IND/CTA/BLA/MAA submissions in a timely and efficient manner in compliance with current regulations and standards. The successful candidate will monitor US, EU, and other regional regulatory CMC requirements and CMC regulatory commitments.

Responsibilities:

• Develop and execute global Regulatory CMC strategies to enable timely and effective submissions and interactions with regulatory health authorities

• Responsible for content development, compilation, maintenance, and review of the Quality Modules for regulatory submissions, including BLA/MAA/INDs/IMPDs, amendments, scientific advice briefing documents, responses to information requests from regulatory agencies, annual updates, and other filings, as applicable

• Lead regulatory CMC review and approval for drug substance and drug product specifications, stability programs and related processes and procedures, as applicable

• Oversee/manage regulatory CMC consultants as needed

• Provide regulatory CMC leadership in interactions with FDA, EMA, and other regulatory authorities as required, CMO vendors, internal global regulatory affairs, technical operations, and cross-functional teams to facilitate alignment on regulatory CMC strategies, optimal approaches for their implementation, and timely completion of associated regulatory filings

• Maintain current working knowledge of applicable regulatory CMC requirements and precedents to inform regulatory approaches for early- through late-stage development products, providing updates to teams and/or functional areas as needed

Requirements:

Education and Experience:

• BS degree in a scientific or life sciences discipline with 15+ years of Regulatory CMC pharmaceutical/biotech experience in biologics - monoclonal antibodies preferred and vaccine experience a plus, OR

• Advanced degree preferred (MS, PhD or PharmD) in a scientific or life sciences discipline with 10+ years of similar experience noted above

• Ability to manage all aspects of CMC regulatory activities from pre-CTA/IND through late-stage clinical development and marketing application submissions

• Effective partnership with Global Regulatory Affairs, Technical Operations, Quality, Regulatory Operations, CMOs and regulatory agencies

• Experience with investigational and commercial products, including registration applications

• Demonstrated experience in the preparation, submission, and maintenance of CMC regulatory filings in collaboration with project teams, including original BLA/MAA, INDs/CTAs, amendments, and Scientific Advice

• Direct regulatory experience with FDA and EMA; global regulatory experience preferred

• Track record of effective collaboration on project teams, and across multiple organizational levels and functions

Competencies and Attributes:

• Ability to build and maintain effective internal and external relationships, including cross-functional teams, regulatory agencies, and contract organizations

• Excellent planning and organizational skills, including the ability to support and prioritize multiple projects, as needed

• Demonstrated ability in effectively applying current CMC regulatory requirements across product pipeline

• Must display strong analytical and problem-solving abilities, and strong attention to detail

• Excellent written and verbal communication skills essential

• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless, and joyful