Senior Manager, Regulatory Strategy
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Manager/Associate Director of Regulatory Strategy for clinical development programs at Praxis Precision Medicines. Leading global regulatory strategies and lifecycle management in biotech/pharma.
Responsibilities:
- Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management.
- Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance.
- Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines.
- Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors.
- Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination.
- Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities.
- Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements.
- Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs.
- Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes.
Requirements:
- Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred; six to ten years of experience in Regulatory Strategy within biotech/pharma.
- Demonstrated experience managing IND lifecycle activities, including protocol amendments, new INDs, and global CTA maintenance.
- Experience supporting health authority interactions and preparing regulatory briefing packages.
- Experience in rare disease and/or neurological indications strongly preferred.
- Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy) and their application to lifecycle strategy.
- Strong project management skills and ability to manage multiple concurrent regulatory activities.
- Excellent communication and collaboration skills.
Benefits:
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
- Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays, and company-wide shutdowns.
Similar Jobs
Senior Quality Compliance Manager
Senior Manager overseeing GMP/GDP inspections for a global biotech company. Leading quality compliance efforts and regulatory interactions to ensure operational excellence.
Senior Specialist, Regulatory Operations
Senior Specialist leading regulatory operations for clinical trials at Care Access. Ensuring compliance with U.S. regulations and supporting site-level activities in a remote role.
US Regulatory Lead
US Regulatory Lead providing regulatory expertise for Amgen molecules. Planning and executing regulatory strategies in compliance with local regulations.
Government Compliance Manager
Government Compliance Manager at Workstreet guiding clients through federal cloud compliance frameworks. Leading teams in FedRAMP, GovRAMP, and NIST 800-53 authorization processes.
Regulatory Manager – Obesity, Related Conditions
Regulatory Manager at Amgen overseeing U.S. regulatory strategy and compliance for Obesity products. Leading clinical trial support and regulatory submissions for product licensing.
Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes
Director providing regulatory leadership for obesity and related conditions at Amgen. Developing global strategies and leading interactions with health authorities.
Compliance Lead
Compliance Lead overseeing end-to-end tax filing and compliance across multiple jurisdictions for a global trade infrastructure startup. Focus on accuracy and scalability with automation in processes.
IT & Compliance Manager
IT & Compliance Manager at LINK, overseeing IT operations and compliance with a focus on federal standards. Leading CMMC certification and managing cybersecurity initiatives in a remote setup.
Risk Management Consultant – GRC Practice
Risk Management Consultant at Artemis Connection helping clients build and mature enterprise risk programs. Focused on strategic, operational, regulatory, and reputational risks with an emphasis on cybersecurity.
Governance Consultant – GRC Practice
Governance Consultant enhancing compliance practices across sectors, assessing current governance, designing structures, and driving adoption. Client-facing role focusing on strategic decision-making in governance and risk.
Compliance Consultant – GRC Practice
Compliance Consultant delivering compliance assessments and advisory engagements across various frameworks for GRC practice. Managing client relationships and contributing to business development activities.
Senior Analyst, Corporate Compliance
Senior Analyst Corporate Compliance at CVS Health overseeing regulatory compliance for Aetna's commercial insurance business. Supporting risk assessments, compliance documentation, and business initiatives for regulatory impact.
Manager, Coding Compliance – Orthopedic Surgery
Manager Coding Compliance tasked with ensuring proper charge capture and coding compliance in orthopedic surgery operations. Supervising staff and interacting with faculty for revenue maximization and compliance.
Manager – Regulatory Reporting, Compliance
Manager overseeing EPR regulatory compliance and reporting processes within National Program Operations Team. Leading development and implementation of compliance framework for EPR programs across multiple states.
Mid-level Regulatory Affairs Analyst – New Registrations
Analista de Assuntos Regulatórios Pleno na Libbs, promovendo saúde de alta qualidade com foco em novos registros.
Global GxP Regulatory Intelligence Compendia Manager
Global GxP Regulatory Intelligence Compendia Manager overseeing ongoing monitoring and management of compendial updates to ensure compliance with regulations. Responsible for reporting and cross-functional collaboration.
Senior Regulatory Affairs Manager – Obesity and Related Conditions
U.S. Regulatory Lead developing and executing regulatory strategies for obesity and related conditions at Amgen. Collaborating with global teams to meet regulatory requirements and maintain licenses.
Global Regulatory Lead, PDx
Global Regulatory Lead overseeing pharmaceutical diagnostics from pre-clinical to registration in global markets. Leading regulatory strategy for new product introductions and compliance obligations.
Manager, Regulatory Compliance
Manager of Regulatory Compliance leading U.S. sportsbook trading operations at DraftKings. Ensuring compliance across jurisdictions and managing a team in a fast-paced environment.
Risk and Compliance Manager – Retail Broking
Risk and Compliance Manager supporting compliance obligations for retail broking businesses in the UK. Providing regulatory guidance while working closely with the Risk & Compliance team remotely.