Associate Director, Regulatory Affairs

Alnylam Pharmaceuticals; Philadelphia (Philadelphia County); Vor Ort; USD 171.000 - 231.000; Vollzeit

Benefits dieser Stelle

Medical/dental/vision

Life/disability

401(k) match

PTO & holidays

Zusammenfassung

Scorpion Therapeutics is seeking an Associate Director of Regulatory Affairs Strategy to lead regulatory strategies for CNS programs, coordinate US HA interactions, and drive submission readiness across early to late-stage programs.

The role requires a strong background in US FDA filings, cross-functional leadership, and strategic thinking to navigate complex regulatory landscapes. This hybrid position offers collaboration with global teams and a chance to shape pivotal regulatory decisions.

Qualifikationen

• Bachelor’s degree with 6+ years in Regulatory Affairs (minimum 8 years biotech/pharma industry).
• Excellent written/verbal communication; negotiation and influencing skills.
• Solid understanding of regulations and experience interpreting guidelines.
• Strategic thinking; proactive issue identification and mitigation.
• Experience with US regulatory filings and leading US FDA interactions.
• Strong organizational/project management; ability to prioritize multiple projects.
• Team-oriented with strong interpersonal skills.
• Technical system skills including submission-ready formatting.
• Alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency.

Aufgaben

• Serve as US Regional Lead or Global Regulatory Lead for CNS programs.
• Lead and define regulatory strategy; compile and submit regulatory documents and lead US HA interactions (INDs, meetings, filings).
• Develop detailed regulatory project plans and support regulatory activities.
• Participate in/lead the Global Regulatory Team and product subteams.
• Coordinate timely responses to regulatory authority questions within deadlines.
• Liaison with internal departments, CROs, and regulatory program managers at HAs.
• Maintain regulatory files per internal requirements.
• Review technical regulatory documentation and recommend changes to docs/processes.
• Provide EU-specific regulatory intelligence as appropriate.

Kenntnisse

Regulatory strategy

FDA interactions

Submissions

Project management

Cross-functional teamwork

Communication

Ausbildung

Bachelor's degree

Jobbeschreibung

Associate Director of Regulatory Affairs Strategy (Hybrid)

Summary of Key Responsibilities

• Serve as US Regional Lead or Global Regulatory Lead for early/mid/late-stage CNS programs.
• Lead and define regulatory strategy; compile and submit regulatory documents and lead US Health Authority (HA) interactions (e.g., INDs, meeting requests/briefing documents, Marketing Applications, Pediatric Plans, Orphan Designation, Expedited Pathway/Breakthrough Designation).
• Develop detailed regulatory project plans and support regulatory activities for assigned portfolios.
• Participate in/lead the Global Regulatory Team and represent Regulatory Affairs on multidisciplinary product subteams.
• Coordinate timely responses to regulatory authority questions within deadlines.
• Liaison with internal departments, CROs, and regulatory program managers at HAs.
• Maintain regulatory files per internal requirements.
• Review technical regulatory documentation and recommend changes to documentation/processes, including SOPs for compliance.
• Provide EU-specific regulatory intelligence as appropriate.

Qualifications

• Bachelor’s degree with 6+ years in Regulatory Affairs (minimum 8 years biotech/pharma industry experience).
• Excellent written/verbal communication; negotiation and influencing skills.
• Solid understanding of regulations and experience interpreting guidelines.
• Strategic thinking; proactive issue identification and mitigation.
• Experience with US regulatory filings and leading US FDA interactions.
• Strong organizational/project management; ability to prioritize multiple projects.
• Team-oriented with strong interpersonal skills.
• Technical system skills (e.g., word processing, spreadsheets, databases, online research) including submission-ready formatting.
• Alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, Passion for Excellence.

Benefits / Compensation (as stated)

• US pay range: $170,900.00–$231,300.00; eligible for annual short-term incentive and annual long-term incentive.
• Comprehensive benefits include medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, and 401(k) match; PTO, wellness days, holidays, recharge breaks, and family leave/resources.