US Regulatory Strategy Lead

🕒 Yesterday

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $185k - $210k / year

⏰ Full Time

🟠 Senior

🧐 Strategy

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• Own all aspects of US Regulatory Strategy for assigned development and marketed products • Provide US-focused product strategy, regulatory framework knowledge, and awareness of external regulatory initiatives to the Global Regulatory Team • Partner with the Global Regulatory Lead and participate in cross-functional MDT and CAT project teams • Present US regulatory positions to Sobi stakeholders • Develop US regulatory strategies, risk assessments, and mitigation strategies • Champion expedited regulatory pathways to accelerate patient access • Prepare cross-functional teams for major FDA meetings and lead or facilitate meetings with the Agency • Lead triage of FDA information requests and Health Authority communications requiring sponsor responses • Contribute to Submission Taskforce efforts for timely, high-quality major submissions • Lead interactions with regulatory consultants and facilitate related communications • Coordinate with Sobi departments, affiliates, regulatory authorities, partners, and consultants • Serve as key FDA contact and communicate FDA feedback and next steps to the business • Support development partners and business partners on assigned products • Contribute to US product labeling with the Global Regulatory Lead and Labeling group • Partner with US Commercial and Ad Promo teams • Be responsible for IND, NDA, and BLA submissions to FDA with Regulatory Operations • Represent Regulatory in due diligence assessments of new business opportunities • Review regulatory SOPs and participate in operational excellence projects • Represent Sobi at industry events and public meetings • Monitor and assess relevant US regulations, guidance, and the current regulatory environment

🎯 Requirements

• BS in a scientific discipline required • 6+ years of regulatory affairs experience • Experience leading health authority meetings with the FDA • Ideal candidate has delivered at least one major NDA, BLA, sNDA, or sBLA application • Immunology late-stage development or marketed-product experience is ideal but not required; other therapeutic areas considered • Strong leadership skills and high emotional intelligence • Strong verbal and written communication skills • Firm commitment to corporate objectives and the highest ethical, regulatory, and scientific standards • Proven sound judgment in risk assessment • Knowledge of new and emerging regulations and guidance • Understanding of GMPs, GLPs, and GCPs • Ability to seek and interpret regulatory information • Fluent written and verbal English communication, presentation, and facilitation skills • High ethical standards and ability to demonstrate Sobi values • Strong negotiation skills and significant experience interacting with regulatory authorities • Risk identification and problem-solving skills • Cross-cultural sensitivity and inclusive behavior • Ability to manage complex issues and coordinate multiple projects simultaneously

🏖️ Benefits

• Competitive compensation • Generous time off policy • Opportunity to attend popular conferences • Emphasis on work/life balance • Collaborative and team-oriented environment • Competitive 401(k) match • Tuition reimbursement • Wellness reimbursements • Comprehensive medical, dental, and vision package • Additional recognition awards • Short-term bonuses • Long-term bonuses • Reasonable accommodation for qualified individuals with a disability or disabled veteran