Regulatory Affairs Cmc Manager

Vor 3 Tagen

Basel, Schweiz SimplyVision GmbH Vollzeit

For our customer located in Basel/Switzerland we are currently looking for a**: Regulatory Affairs CMC Manager **(M/F/x)
**Tasks & Responsibilities / Must Haves**
- Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA’s on REG CMC questions to support new product or post marketed launches.
- ~Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.

~No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
~Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders
~RA CMC regulatory documentation follows our client guidelines & meets regulatory guidelines.
~Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems. ~Maintains collaborative partnerships with stakeholders.**Major Accountabilities**
- Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timeliness 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 stake holders.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.

**Education / Language / Experience**
**Education**:

- Minimum: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.

Desirable: Advanced Science Degree

**Languages**:

- Fluent English required (oral and written). Excellent written/spoken communication skills.

**Experience**:

- Working knowledge/experience in regulatory submission and approval processes desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the product development and life cycle desirable.
- Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
- Effective planning, organizational and interpersonal skills.
- Computer/IT systems literacy

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