Vice President, Regulatory Affairs - United States
This position will lead the global regulatory submission of sulopenem as well as preside over the company’s overall regulatory strategy. The position will lead the regulatory affairs team as well as work closely with the clinical development team and external consultants to advance the company’s development programs. The Vice President, Regulatory Affairs will be a key member of the product development leadership team with the anticipation that the successful candidate will contribute to the strategic direction of the development programs and assure they are designed to meet regulatory approval standards on a global basis.
The primary responsibilities of this role include, but are not limited to:
- Lead, manage and coordinate global regulatory activities for the company’s portfolio in collaboration with the Clinical Development Team.
- Develops and implements regulatory strategies, including regulatory risk management ensuring that any RA issues are highlighted and addressed satisfactorily.
- Presents and defends the regulatory strategy internally to relevant groups (project team, development team, senior management, etc.).
- Provides support for all development and life cycle management projects.
- Manages and monitors the preparation, assembly and filing of regulatory submissions to support new product approvals and existing brands.
- Manages submission process with corporate partners and consultants.
- Manages and coordinates responses to answer regulatory agencies requests.
- Offers regulatory support and advice to all departments within Iterum.
- Builds and maintains a strong relationship with external and internal contacts.
- Ensures high quality and professional interactions with health authorities including participation in key formal and informal Health Authorities contacts.
- Participates in the review of labeling and promotional material to ensure compliance with regulations.
- Supports business development efforts.
- Represents the regulatory group at specific internal and external meetings.
- Develop and maintain in-depth knowledge of company’s and competitors’ programs.
- Plan and initiate studies/projects required for regulatory responses.
- Triage and coordinate external research requests.
- Manage the global regulatory affairs team at Iterum.
- Prepare and track budget for regulatory operations.
- Develop and maintain the policies and procedures for full regulatory compliance.
- Oversee clinical quality assurance activities for the company.
Training and Education:
- Master’s or PhD in a relevant life science discipline is required
- Minimum of 15 years of experience in regulatory affairs within the biotech or pharmaceutical industry and at least 10 years of relevant North American and Global Regulatory experience.
- Track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical/biotech compounds.
- Experience in a successful leadership role in developing and managing a team capable of developing and registering candidate drugs through to marketing approval.
- Acute sense of ethics and ability to work in a highly regulated environment.
- Excellent knowledge of European and American regulatory requirements.
- Track record of outstanding accomplishments with regulatory agencies, specifically with the FDA and international regulatory authorities.
- Experience in actively participating in a due diligence evaluation.
- Excellent understanding of the drug development process.
- Ability to build effective relationships with health authorities as well as with internal stakeholders and employees.
- A credible individual who can lead a team and influence and work well with physicians, scientists, peers and managers.
- A results oriented, focused, pro-active person who can diagnose issues, learn from mistakes, solve problems and provide alternative solutions.
- An individual who demonstrates humility, good judgment and strong analytical skills and adjusts quickly to changes.
- Excellent organizational and project management skills and ability to think strategically.
- Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.
- A person who can integrate into the environment, operate as part of an effective team, listens well and make important decisions.
- Strong curiosity, intelligence, ability to think strategically and independently
- “Hands on” approach; willing to do what it takes
- Ability to build good working relationships internally and externally and an entrepreneurial spirit.