Manager/Sr. Manager, Regulatory Affairs & Strategy
- Provide regulatory strategic leadership and tactical support to Regulatory Functional Teams for assigned products.
- Support maintenance of the global regulatory strategy (development and life-cycle management) to accelerate development and maximize the value of regulatory approvals
- Support clinical trial and marketing application filings, review/ approval and maintenance of these authorizations where appropriate.
- Represent Regulatory Affairs on cross functional development and commercial teams where appropriate.
- Demonstrate excellent leadership and interpersonal skills and the ability to prioritize multiple tasks.
Regulatory Strategy Leader on assigned product(s)
- Support Regulatory Affairs Functional Teams to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
- Support developing and creating global / regional regulatory strategies for multiple projects at all stages (Phase 1 through market authorization) and life-cycle management.
- Support authoring and / or review regulatory documents for submission to US and/or Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs, MAAs, orphan, Breakthrough, etc.)
- Support the preparation for and conduct of formal meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
- Identify and escalate potential Regulatory issues to executive management and propose risk evaluations and mitigation strategies.
- Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
- Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with application regulations and at the highest level of ethical standards.
- Support maintenance of Regulatory Strategic Development plans and provide strategic input to global project development plans.
- Bachelor’s Degree in a relevant scientific discipline. Master’s or an advanced degree (PhD, Pharm D, MD) is preferred.
- 3 years of direct regulatory affairs experience, including leading/supporting IND/ CTA application and Health Authority meetings and supporting submission of marketing applications (NDA, BLA, MAA) in the US, EU or both.
- Standard computer proficiency.
- Strong written and oral communication skills and the ability to interact effectively with cross-functional project teams.
- Ability to manage regulatory affairs activities in a “hands-on-fashion” while utilizing a strategic approach in all aspects of global development and compliance.