Location: Switzerland - Glattbrugg/Zurich
Function: Regulatory Affairs
Company: Vifor Pharma
We are currently looking for an experienced Regulatory Affairs Clinical Support Director. You will be responsible to support Global Regulatory Affairs (GRA) Therapeutic Area Heads and Team Leads in developing and evaluating clinical strategies to ensure the effective achievement of regulatory and business objectives. Based at our Operational Headquarters in Glattbrugg/Zurich, you will report to the Head of Regulatory Affairs Centre of Excellence. Tasks and responsibilities will include:
- Act as key SME for general considerations related to regulatory frameworks governing clinical research, and provide input for GRA Therapeutic Area leads and Clinical Study Team members on conditions for building regulatory dossiers to support the safety, efficacy, medical benefit, and market access of drug and product candidates on a global basis.
- Collaborate with key stakeholders (especially within clinical, medical, regulatory and safety functions) on relevant long-term R&D objectives regarding clinical development processes, functional capabilities, and clinical design strategies.
- Keep informed about and address key regulatory trends related to clinical development and clinical requirements supporting new product approval and communicate to appropriate management functions.
- Manage Clinical Support staff within GRA, including providing guidance and advice to staff to achieve goals related to regulatory support of clinical development.
- Represent GRA on internal clinical review governance groups, including the Protocol Review Committee (PRC), the First-in-Human Clearance Committee (FIH CC), and the Phase IV Review Board (PRB).
- Act as key GRA contact point for development of cross-functional R&D clinical procedures, and for organisational structure and systems related to clinical research.
- Act as GRA lead for initiatives related to GCP compliance and related to regulatory requirements around clinical transparency and results disclosure .
- Provide guidance to GRA staff in interpreting public information related to approval of products within the therapeutic areas of Vifor involvement and within the competitive landscape. (e.g. evaluation of competitor EPARs and FDA Advisory Committee reports for key products.)
- Review and ensure that the design and conduct of clinical development programs and individual studies are appropriate to generate data supportive of GRA submissions and business/marketing objectives.
- Provide regulatory support to corporate due diligence activities requiring evaluation of clinical programs.
The ideal candidate will bring an advanced degree, preferably in pharmaceutical or health related field, in additional to the following experience:
- 10-12 years’ experience with clinical development programs within regulatory affairs in the pharmaceutical industry (prescription drugs)
- Demonstrated experience managing clinical aspects of regulatory strategy and submission of dossiers including study design, data review, approval strategies and labelling negotiations
- Solid knowledge of the global regulatory environment and GCP regulations
- Experience in anaemia, nephrology or speciality drug development is an advantage
You demonstrate strong communication skills with ability to efficiently and productively communicate orally and in writing. Your excellent planning and organisational skills, combined with the ability to understand complex concepts, enable you to elaborate suitable strategies and implement process improvements. You are able to multitask and manage multiple and changing priorities with the ability to prioritise and delegate.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.