Ra Cmc Manager

Vor 4 Tagen

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
583 That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your help. As manager, you provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mindset.

**About the Role**:
**RA CMC Manager - Cell & Gene Therapies**

**Your Responsibilities include but are not limited to**:

- Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Cell & Gene Therapy projects/products.
- Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
- Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
- Initiate and lead Health Authority interactions and negotiations.

**What You’ll Bring To The Role**
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload
- Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
- Good oral and written communication skills with a collaborative and patient-focused mindset
- Computer/IT systems literacy

**Desirable Requirements**
- Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired
- Ideally, at least 2 years’ experience in regulatory CMC experience and/or pharmaceutical industry experience; working knowledge in regulatory submissions desirable.
- Demonstrated working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Ability to critically evaluate data from a broad range of scientific disciplines.

**Commitment to Diversity & Inclusion**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.


Division

Development

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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