US Regulatory Strategy Lead

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Take charge of all facets of US Regulatory Strategy for both development and marketed products assigned to you.

• Deliver US-centric product strategy, regulatory framework expertise, and insights into external regulatory initiatives to the Global Regulatory Team.

• Collaborate with the Global Regulatory Lead and engage in cross-functional MDT and CAT project teams.

• Communicate US regulatory positions to Sobi stakeholders effectively.

• Formulate US regulatory strategies, risk evaluations, and mitigation plans.

• Advocate for expedited regulatory pathways to enhance patient access.

• Prepare cross-functional teams for significant FDA meetings and lead or facilitate discussions with the Agency.

• Oversee the triage of FDA information requests and communications from Health Authorities that necessitate sponsor replies.

• Contribute to Submission Taskforce initiatives for timely and high-quality major submissions.

• Direct interactions with regulatory consultants and streamline related communications.

• Liaise with Sobi departments, affiliates, regulatory bodies, partners, and consultants.

• Act as the primary FDA contact and convey FDA feedback and next steps to the business.

• Support development and business partners with assigned products.

• Collaborate with the Global Regulatory Lead and Labeling group to contribute to US product labeling.

• Partner with US Commercial and Ad Promo teams effectively.

• Oversee IND, NDA, and BLA submissions to the FDA in conjunction with Regulatory Operations.

• Represent Regulatory in due diligence evaluations of new business opportunities.

• Review regulatory SOPs and engage in operational excellence initiatives.

• Represent Sobi at industry events and public forums.

• Monitor and evaluate pertinent US regulations, guidance, and the prevailing regulatory landscape.

⛳️ Requirements

• Bachelor’s degree in a scientific field is required.

• A minimum of 6 years of experience in regulatory affairs.

• Proven experience leading meetings with health authorities, particularly the FDA.

• The ideal candidate should have successfully delivered at least one major NDA, BLA, sNDA, or sBLA application.

• Experience in immunology late-stage development or marketed-product is preferred but not mandatory; other therapeutic areas will also be considered.

• Strong leadership abilities combined with high emotional intelligence.

• Excellent verbal and written communication skills.

• A strong commitment to corporate objectives and adherence to the highest ethical, regulatory, and scientific standards.

• Demonstrated sound judgment in risk evaluation.

• Familiarity with new and emerging regulations and guidance.

• Understanding of GMPs, GLPs, and GCPs.

• Capability to seek and interpret regulatory information effectively.

• Fluent in written and spoken English with strong communication, presentation, and facilitation skills.

• High ethical standards and the ability to embody Sobi values.

• Strong negotiation skills with substantial experience engaging with regulatory authorities.

• Proficiency in risk identification and problem-solving.

• Awareness of cross-cultural sensitivities and inclusive conduct.

• Ability to manage complex issues and coordinate multiple projects simultaneously.

🏝️ Benefits

• Competitive compensation package.

• Generous time off policy.

• Opportunities to attend popular conferences.

• Focus on work/life balance.

• Collaborative and team-oriented workplace.

• Competitive 401(k) matching.

• Tuition reimbursement available.

• Wellness reimbursement program.

• Comprehensive medical, dental, and vision insurance.

• Additional recognition awards.

• Short-term and long-term bonuses.

• Reasonable accommodations for qualified individuals with disabilities or disabled veterans.