Head of Global Regulatory Strategy, Immunology

Vor 2 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.**

**Head of Global Regulatory Strategy, Immunology**

**Role & Function**The Head of Global Regulatory Strategy is responsible for providing strategic regulatory leadership to the assigned Sobi portfolio. This includes the development of global regulatory strategies for all assets in the portfolio as well as regulatory strategy and execution in the US, EU, Switzerland and the UK.

The job holder will act as Global Regulatory Lead for one asset and oversee a team of Global Regulatory Leads and US/EU strategy leads.

**Key Responsibilities**

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Lead the global regulatory strategy and main regulatory interactions to support development, registration and launch of Sobi products
- Act as single point of accountability within Global Regulatory Affairs on Core Asset Team (CAT) for assigned program
- Chair Global Regulatory Team
- Develop innovative regulatory strategies including the use of expedited regulatory pathways globally
- Assess probability of regulatory success, highlighting risks and mitigation strategies
- Develop global filing sequencing for assets in development
- Lead major regulatory interactions globally

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Responsible for regulatory strategy and execution in the US, EU, Switzerland and the UK for all assigned programs in the portfolio

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Oversight of regulatory strategy in Japan and direct point of contact with Japan Regulatory Affairs leads

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Lead interactions with Alliance partners (e.g. attendance of joint Development Committee) as needed

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Coach and mentor GRLs and other team members

Member of the Global Regulatory Affairs leadership team

**Qualifications**

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PharmD or PhD preferred with minimum 15 years of experience in Regulatory Affairs within the pharmaceutical industry with >7 years of specific leadership and organizational management experience

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Extensive experience with interactions with global regulatory authorities required (FDA, EMA, PMDA, NMPA)

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Experience leading regulatory interactions throughout all stages of lifecycle including registration and line extensions of existing products

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Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities

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In-depth understanding of the drug development, product commercialization and life cycle management processes combined with experience in Quality Assurance, Development, Clinical and Compliance is desired

Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards

**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.
- Functional competencies, including but not limited to organization, financial and budget planning, prioritization and planning skills, negotiation skills, communication & presentation skills
- Able to think globally and contemplate multiple aspects and impacts of issues and plan proactively
- Understands how to empower others, lead leaders and collaborate in a global team environment at all levels of the organization.
- 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 or Stockholm or Boston, Switzerland.

**Reporting to**Vice President, Head of Global Regulatory Affairs

**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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