Eu Regulatory Strategy Lead Hemophilia

Vor 6 Tagen

Basel, Schweiz Sobi Vollzeit

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**

**EU Regulatory Strategy Lead Hemophilia**:
**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.

**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 labelling; 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**
- 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)- 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
- Ability to manage complex issues and coordinate multiple projects simultaneously

In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**
The position will be based in Basel, Switzerland.

**Reporting to**
Head of Regulatory Strategy, Pegcetacoplan & Hemophilia

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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