Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients. and our edge comes from our team of people.

We know that the culture at Sobi North America is something to brag about, but here are some more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Fitness equipment and/or gym membership reimbursements
• Discounted pet insurance
• Opportunity to broaden your horizons by attending popular conferences
• Summer Friday’s
• Emphasis on work/life balance

Role & Function

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 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.

**Please note this position is remote with expected travel to our headquarters in Waltham MA and Durham NC

Key Responsibilities

• 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
• 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)
• Drives 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
• May represent Sobi on industry work events and attend public meetings

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 or BLA)
• 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

The base salary pay range for this role is $105,000-$145,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

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

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.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans.

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 irina.conc@sobi.com

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 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, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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 asset, 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 can’t 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.

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