Sr. Director/Vice President, Global Regulatory Affairs
The Sr. Director/Vice President, Global Regulatory Affairs, reporting to the Chief Regulatory Officer, will provide strategic and operational regulatory leadership to advance the development of innovative therapeutic products. The successful candidate will oversee regulatory filings and communications for investigational products, which may include monoclonal antibodies, vaccines and/or small molecules.
- Provide or oversee regulatory leadership on project team(s), collaborating with senior leaders and cross-functional team members on development and implementation of regulatory strategies to advance the progress of investigational products consistent with overall program strategy and regulatory requirements; anticipate and mitigate strategic risks
- Execute regulatory strategies and perform critical data assessments to enable timely and effective preparation, review, and submission of key regulatory filings
- Recruit, mentor, and direct a team responsible for regulatory submissions such as original INDs/CTAs/BLAs/MAAs, meeting requests and briefing documents, responses to Agency requests, and maintenance submissions in conjunction with Regulatory Operations and Regulatory Writing
- Establish and maintain effective ongoing communications with FDA and other Regulatory Agencies, as applicable for development programs
- Support the initiation, conduct and completion of clinical trials, including the review of clinical protocols and study reports, in collaboration with other functions such as Clinical Development, Clinical Operations, Global Safety & Pharmacovigilance, Data Management and Biostatistics
- Maintain and expand working knowledge of applicable regulatory requirements and precedents to inform both regulatory strategies and requirements for development programs, providing updates to project teams and/or functional areas as needed
- Guide selection and ongoing management of regulatory contractors and CROs to ensure timely and effective regulatory communications and compliance; manage members of regulatory team
- Additional responsibilities include preparation and/or review of SOPs, budget and other activities, as needed
Education and Experience:
- Advanced or Bachelors degree in a scientific discipline; life sciences preferred
- >15 years of regulatory experience, preferably with at least 10 years in a pharmaceutical or biotechnology company focused on novel therapies; experience with rare and neurodegenerative diseases preferred
- Ability to manage all aspects of regulatory activities from pre-IND through late-stage clinical development, including oversight of Regulatory Operations and CMC Regulatory; product registration/commercial experience required
- Demonstrated hands on experience leading preparation, submission, and maintenance of key regulatory filings, in collaboration with project teams
- Prior FDA regulatory liaison and global experience required
- Prior experience managing a team required
- Track record of effective collaboration on project teams, and across multiple organizational levels and functions
Competencies and Attributes:
- Demonstrated leadership to drive results that are needed to achieve company objectives in accordance with Prothena’s culture and values – courageous, imaginative, selfless and joyful
- Ability to build and maintain effective internal and external relationships, including cross-functional teams, regulatory agencies and contract research organizations
- Excellent strategic, planning and organizational skills, including the ability to support and prioritize multiple projects, as needed
- Demonstrated competence in understanding and effectively applying current regulatory requirements in an emerging regulatory landscape
- Must display strong analytical and problem-solving abilities
- Excellent written and verbal communication skills essential
Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.
We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.
Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).
Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.