About the Opportunity
We are currently partnered with a growing biopharmaceutical company in need of a Manager/Sr. Manager/Associate Director of Regulatory Affairs Strategy to join their team! This company currently has an FDA approved product on the market with a robust pipeline in Rare Disease, Hematology and Neuroscience. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies that support the success of their pharmaceutical products.
The annual base salary range is $140,000 to $170,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
- Serve as a liaison to FDA and provide strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provide oversight to regulatory consultants and vendors where applicable
- Provide regulatory strategic support and guidance across all functions
- Routinely perform regulatory precedence and competitive intelligence research
- Contribute to identification of potential issues/gaps and propose creative risk mitigation strategies to address gaps affecting optimal and timely submission and approval
- Assess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines
- Support and/or lead the planning and execution of global health authority interactions including support in generation and submission of briefing books, meeting preparations
- Assist and/or lead in planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines
- Interpret and communicate health authority correspondence effectively and quickly to senior leadership and project teams
- Advanced degree (Masters, PharmD, PhD, MD) preferred
- Experience in Oncology/Rare Disease is preferred
- 3+ years of regulatory experience within industry