US Regulatory Strategy Lead

The US Regulatory Strategy Lead is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products. He/she is a critical member of the Global Regulatory Team (GRT) providing US-focused product strategy US regulatory framework knowledge and awareness of external regulatory initiatives. The US Regulatory Strategy lead partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams including MDT and CAT representing Regulatory on an agenda driven basis. The US Regulatory Strategy Lead will present the US regulatory position on assigned products to Sobi Stakeholders as needed.  The USRL develops US regulatory strategies including risk assessments mitigation strategies and champions use of expedited regulatory pathways for accelerated patients access in the US

Key responsibilities including but not limited to the following:

• Core member of the GRT collaboratively working with the team to weave US strategies into global strategies as they are developed
• US participant on Sobi Product Cross Functional Teams as appropriate
• Point of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT) for assigned program(s)
• Ensures guidance on regulatory pathways to accelerate product development (e.g. ODD FTD Accelerated Approval Priority Review etc.) is evaluated and included where possible in the US Strategy
• Prepares cross-functional team for any major FDA Meetings and leads/facilitates major meetings with the Agency
• Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA
• Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions of major application(s) is executed successfully
• Point of contact and lead with regulatory consultants and facilitates meetings and any communications shared between regulatory and its consultants
• Cooperates with other departments and affiliates within Sobi regulatory authorities partners and regulatory consultants
• Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps
• Key contact for development and business partners on product(s)
• Contributes to US product labeling working with the GRL and Labeling group to ensure core label changes are appropriately conveyed in US product labeling; Partners with US Commercial and Ad Promo Team
• Responsible for IND NDA and BLA submissions to FDA in partnership with Regulatory Operations
• Regulatory representative on due diligence assessments of new business opportunities as required
• Reviews regulatory SOPs as needed
• Participates in operational excellence work (improvement projects) as needed
• May represent Sobi on industry work events and attend public meetings
• Monitors and assesses impact of relevant US regulations guidance and current regulatory environment

Qualifications :

Education/Learning Experience/Work Experience

• BS in a scientific discipline. Advanced degree (PhD PharmD MD) preferred but not required
• 6 years regulatory affairs experience having led health authority meetings (FDA). Ideal candidate will have delivered at least one major application (NDA/BLA or sNDA/sBLA)
• Experience with immunology late-stage development/marketed products ideal but not required. Other therapeutic areas will be considered
• Great leadership skills with high emotional intelligence
• Must be a great team player with strong verbal and written communication skills

Skills/Knowledge/Languages

• Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical regulatory and scientific standards
• Proven track record practicing sound judgment as it relates to risk assessment
• Highly conversant and knowledgeable of new and emerging regulations and guidance. Understanding of GMPs GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information
• Fluent written and verbal communication presentation and facilitation skills in English

Personal Attributes

• High ethical standards and ability to demonstrate Sobi values Strong negotiation skills and significant experience in interacting with regulatory authorities
• Risk identification and problem-solving skills
• Actively demonstrates cross cultural sensitivity and inclusive behavior 
• Ability to manage complex issues and coordinate multiple projects simultaneously

Additional Information :

Compensation and Total Rewards at Sobi

At Sobi we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is USD. Each individual offer will be determined based on several factors including your experience qualifications and location. Additionally this role is eligible for both short-term and long-term bonuses as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable assets and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to   

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Remote Work :

Yes

Employment Type :

Full-time