Cmc Dossier Manager
vor 2 Wochen
**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.**
**CMC Dossier Manager**:
**Role & Function**
The CMC Dossier Manager works in the Sobi Technical Operations Department within in the CMC Program Management unit. The role is responsible for technical oversight and the coordination of generation of CMC documentation. Within the scope is the source documentation for process development, process validation, GMP and non-GMP manufacture of drug substance, drug product and finished product, both for clinical and marketed products from a regulatory perspective. The Dossier Manager will coordinate between SME’s, Global Regulatory Affairs and External Manufacturing and Development organizations to ensure in-time generation of high-quality CMC modules for development products. The CMC Dossier Manager role also entails the support of CMC variations, Health Authority requests and the Life Cycle Management for the global expansion of Sobi’s marketed product portfolio.
**Key Responsibilities**
- Provide leadership to ensure development and life-cycle management of Sobi’s products from a technical and regulatory perspective.-
- Compile sections of the Module 3 and 2.3 as required.- Support meetings with Regulatory Agencies (Advice Meetings, Pre-Filing and others) and manage negotiations to resolve CMC issues. Provide support for preparation of meetings with Health Authorities including preparation of briefing packages.- Liaise with Global Regulatory functions and partner organizations or external consultants as appropriate.- **Qualifications**- 8 years plus of experience in CMC development activities for Biologics and/or Small Molecules.- 5 years plus experience in regulatory aspects regarding Chemistry, Manufacturing and Control of Manufacture as well as development.- Excellent project management skills, attention to detail and the ability to manage a team.- Effective verbal and written communication skills.- Good level of oral and written English- Good knowledge of cGMP's and the know-how to work and manage within the highly regulated pharmaceutical environment.**Personal attributes**:
- Strong leadership qualities including strategic thinking, communication, organization and out-of-the-box thinking. - Able to identify problems and implement solutions in ambiguous environment. - Able to balance and communicate risks appropriately. - Able to convince internal and external partners. - Good organizational and communication skills, both written and oral skills, and “do-what-it-takes” attitude. - Independently motivated, detail-oriented and good problem-solving ability. - Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment. In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
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.
**Recruitment contact & how to apply**
**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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