Global Regulatory Affairs Clinical Solutions

Vor 7 Tagen

Glattbrugg, Schweiz Vifor Pharma Vollzeit

-CSL Vifor is a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, we are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. A position has arisen within the Global Regulatory Affairs function in our Clinical Solutions Team for Manager to focus on clinical support of development compounds across the whole Vifor Pharma portfolio.

You will support regulatory product strategy development teams to evaluate and execute clinical regulatory strategies and protocols to achieve business objectives, approvals and optimal labels as well and maintain current regulatory and clinical intelligence with respect to the changing landscape of clinical development strategies

Working cross functionally internally (clin ops, clin development, therapeutic RA, labelling etc) and with external partners and providing vendor (CRO) oversight as well as CSL Vifor Clinical Study teams.

We are looking for a seasoned individual from CRO or sponsor side who has demonstrable expertise of the above with exceptional communication and stakeholder management skills.

Key Measurements of Success
- Demonstration of timely and proactive information of GRA Product Strategy leads and product RAFT of relevant clinical activities
- Successful demonstration of support for key design elements of CSL VIFOR sponsored clinical studies
- Effective collaboration with relevant functions and teams within the company and affiliates on clinical matters
- Successful demonstration of GRA compliance with CSL VIFOR and external standards related to GCP as evidenced through audits, inspections and Clinical Study team (CST) reviews
- Regulatory documents are inserted in Trial Master Files (TMFs) and available for end of trial audit for trials within the designated area of responsibility
- Clinical trials details and data for CSL VIFOR activities maintain on clinical transparency sites in accordance with internal procedures and regulatory requirements
- Demonstration of timely maintenance of clinical submissions (monitoring and archiving) on relevant GRA IT systems
- Understanding of relevant Health Authority clinical regulations, guidance, procedural requirements and data transparency

**Responsibilities**:

- Support GRA Clinical Study Teams (CST) members in the development and monitoring of long & short-term product regulatory planning related to the set-up, conduct, and completion of clinical trials.
- Act as primary representative for GRA on assigned CSTs and as deputy/back-up for GRA CST member as appropriate
- Support GRA Product Strategy Leads and Regulatory Affairs Functional Teams (RATFs) with the coordination and preparation and global submission oversight of clinical submissions to Health Authorities.
- Support GRA CST members in the auditing and records management for the regulatory sections of clinical trial master files,
- Monitor submission procedures (Health Authorities) and archive submissions using the relevant GRA IT systems
- Support the setting up and the completion of global transparency strategies for assigned clinical trials, oversee posting of synopsis and study results on relevant international registers (EUDRACT, CT.gov)
- Represent GRA on cross-functional initiatives related to clinical processes, e.g. CMRS QA GCP compliance initiatives, GCP related audits & inspections, CMRS clinical PDs and documentation systems.
- Support development of CSL Vifor cross-functional R&D clinical procedures, and for organizational structure and systems related to clinical research.
- Monitor national and international registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to GRA staff.

**Requirements**:

Minimum Requirements
- University degree, preferably in pharmaceutical or health related field
- 4 - 8 years’ experience in clinical development or regulatory affairs in the pharmaceutical industry (prescription drugs)
- Proven, first-hand experience of working in a fast-paced team environment
- Experience in working in a multinational regulatory affairs environment within the pharmaceutical industry
- Familiarity with the global regulatory environment and GCP regulations
- Familiarity with CTA/IND processes to support multinational clinical trials
- Good computer skills, including proficiency with MS Office (including Word and PowerPoint)

Other Preferred Requirements
- Experience with eDMS, records management, or catalogue database systems

Languages:

- Professional in English (oral and in writing)
- Proficiency in German or French an advantage

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