Cmc Dossier Specialist/cmc Dossier Manager

vor 4 Wochen

Wien, Österreich Sobi Vollzeit

**CMC Dossier Manager**

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**
- Master’s in Biotechnology, Chemistry, Pharmacy or equivalent and strong knowledge in scientific and technical aspects of pharmaceutical development and manufacturing in a GMP environment.
- 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.

**Location**

The position will can be based remote across Europe, however travel to our Basel office is required.

**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**

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