This biopharmaceutical company is developing and commercializing an innovative pipeline of cancer therapies. They are seeking an Executive Director, Regulatory Strategy who can develop and implement global regulatory strategies while managing a small team of Regulatory professionals. Reporting into the SVP of Regulatory & Quality, you will manage assets through all phases of development and work closely with Health Authorities. This company offers an innovative pipeline, a strong cash position, and a collaborative company culture. With one approved product and another approval pending, now is an exciting time to join this growing organization!
Responsibilities:
- Develop, direct, and lead global regulatory strategies for a portfolio of innovative oncology programs across all phases of development.
- Oversee and manage the timely preparation of accurate regulatory filings, INDs, CTAs, NDAs and MAAs, and ensure the regulatory submissions required to maintain regulatory filings.
- Ensure practices are in conformance with the latest Health Authority and Industry submission standards in the US and EU.
- Provide regulatory strategic leadership to Asset Strategy Teams for the development and life cycle management of assigned products. This includes but not limited to global regulatory strategy, operational submission strategy, health authority interactions strategy, and other regulatory requirements in line with corporate objectives and timelines.
- Collaborate with senior stakeholders across functions to align regulatory strategies with business goals.
- Accountable for value added regulatory health authority interactions and the development of innovative regulatory strategies.
- Ensure strategic messaging and content of global regulatory dossiers.
- Proactively anticipates and mitigates regulatory risks and ensures compliance with global regulatory requirements.
- Accountable to concisely articulate regulatory risks and develop risk-mitigation strategies whilst evaluate opportunities to accelerate development in a fast-paced, dynamic environment.
- Provide leadership, direction, and contribute hands-on to the regulatory team in managing, planning, coordinating, and preparing regulatory documentation.
- Lead and mentor a team of regulatory strategists, focusing on staff development.
- Monitor and assess the global regulatory landscape to inform business and product development strategies.
- Accountable for actively maintaining a contemporary working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business.
Qualifications:
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- 15+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs strategy roles.
- Five or more years in a strategic leadership role.
- Must have strong Regulatory experience in the oncology therapeutic area.
- Requires a demonstrated proficiency in developing and executing global regulatory strategy with extensive demonstrated experience in the US.
- Has direct experience driving regulatory acceleration strategies, innovative regulatory strategies, analyzing regulatory precedence and operational excellence in execution of regulatory strategy.
- Direct experience in late phase drug development, global submission processes and life cycle strategies.
- Must have prior experience working on major market applications (NDA, BLA, or MAA).
- Experience effectively leading in a complex and matrix environment.
- Strong experience directly interfacing with health authorities in multiple major global markets.
- Demonstrated cross functional and leadership in the field.
- Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy.
- Cross functional partnering skills, team-oriented and ability to drive outcomes are necessary skills in the environment.
- Strong business acumen and strategic thinking capabilities, able to navigate complex challenges and contribute to the business’s long-term vision.
- Must be solution oriented with demonstrated skills to innovate, analyze, solve problems, and foster a collaborative working environment.
- Excellent communication skills, with the ability to articulate complex issues clearly and persuasively to a diverse stakeholder group.
- Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.
This is a hybrid position and the Executive Director must be in the office 1-2 times per quarter. Our client has offices in the NY/NJ area and also in the Boston area. Candidates in the Northeast are strongly preferred.
The budgeted salary range for this position is US$275,000 to $300,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.