100% Remote role
Updates from manager
- Prior exp in IVD
- Support process development
- Project support: regulatory perspective, working with stakeholders
- Regulatory strategy input
- Providing higher level documentation in SOP
- Having exp as part of similar role in pharma organization
Prior exp in regulatory role in IVD or biomarker company
- Bachelors in scientific discipline; A minimum of 10 years pharmaceutical industry experience in in clinical regulatory affairs, inclusive of at least 7 years’ experience in a senior regulatory leadership role formulating strategy and driving decision-making. Advanced degree preferred.
Responsibilities will include, but are not limited to, the following:
- Serve as Global Regulatory Strategy Leader for late stage marketed product with multiple indications
- Develop and create strategy for long-term planning at a cross functional level for product, consistent with the corporate and project objectives.
- Represent regulatory in senior management discussions and present issues accordingly.
- Interface with international affiliates on regional regulatory strategy and implementation plans.
- Provides strategic direction to Regional Regulatory Strategy Lead in preparing teams for project related interactions with Regulatory Agency (ies).
- May engage with Regulatory Agency (ies) on project related interactions.
- Provide innovative solutions to challenging opportunities.
- Responsible for the development of global regulatory strategies, in collaboration with the Global Regulatory Team and Strategic Regulatory Intelligence and Policy, which are consistent with the global Project Team goals and objectives.
- Accountable for ensuring the appropriate implementation of the global regulatory strategy.
- Identify issues proactively (i.e. regulatory or competitive) that will impact programs and provide strategies to address them. Communicate these issues to the Global regulatory strategy leader, global regulatory sub-team and to functional management.
- Provides insight and recommendations on health authority guidance in collaboration with the strategic liaison, policy, and regulatory intelligence group.
- Conduct Business Development diligence efforts, if assigned.
- Be a strategic partner and team player in the various decision-making committees within the company.
- Manage up to at least 2 direct reports.
- Engage with patient support services at Client to maximize regulatory and development strategies.
- Completed Bachelor’s degree in a scientific discipline required.
- Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years’ experience in a senior regulatory leadership role formulating strategy and driving decision-making.
- Must be able to travel overnight for business 15% or more, depending on project needs.