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Eu Regulatory Strategy Lead, Hemophilia Associate
vor 1 Monat
**Role & Function**
The EU Regulatory Strategy lead is responsible for all aspects of the EU, Switzerland and GB Regulatory Strategy for assigned development and marketed products. He/she is a critical member of the Global Regulatory Team (GRT) providing European-focused product strategy, European regulatory framework knowledge, and awareness of external regulatory initiatives. The EU Regulatory Strategy lead partners with the Global Regulatory Lead (GRL) and will participate in cross-functional project teams representing Regulatory on an agenda driven basis. The EU Regulatory Strategy Lead will present the European regulatory position on assigned products to Sobi Stakeholders, as needed.
**Please note this is a hybrid role (in Basel office/remote)
**Key Responsibilities**
- Core member of the GRT collaboratively working with the team to weave EU/GB/Switzerland strategies into global strategies as they are developed
- Responsible for CTA, MAA, variations and life-cycle management submissions in the EU, GB and Switzerland in partnership with Regulatory Operations
- Contact point with EMA and MHRA on assigned product(s). Ensures communications from EMA/CHMP/MHRA are properly communicated to the business after assessing the feedback and outlining next steps
- Key contact for development and business partners in Switzerland
- Drives EU/GB/Swiss product labeling, working with the GRL and Labeling strategy group to ensure core label changes are appropriately conveyed in local/regional product labeling; Partners with European Commercial Team
- Participant on Sobi Product Cross Functional Teams as appropriate
- 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_
- _ Experience with haemophilia late-stage development/marketed products ideal but not required. Other therapeutic areas will be considered_
- _ Experience interacting with regulatory authorities as primary company contact on submissions and/or in health authority meeting(s)_
- 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_
- _ Great leadership skills with high emotional intelligence_
- _ Must be a great team player with strong verbal and written communication skills_
- _ Fluent written and verbal communication, presentation, and facilitation skills in English_
Personal Attributes
- _ High ethical standards_, ability to demonstrate Sobi values, _strong negotiation skills and _
- _Risk identification and problem-solving skills_
- _ Actively demonstrates cross cultural sensitivity and inclusive behavior_
For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.
**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
