Regulatory Affairs CMC Specialist

☞ Vifor Pharma

Vue: 153

Jour de mise à jour: 24-04-2024

Localisation: St. Gallen St. Gallen SG

Catégorie: Ventes Informatique Pharmacien / Représentants pharmaceutiques

Industrie: Pharmaceutique et biotechnologie

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le contenu du travail

Vifor Pharma 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. At this time we are looking to add to our team a Regulatory CMC Specialist to focus on post marketing support to our existing portfolio of products.

This position will suit an individual looking to build on their career in the pharmaceutical industry from the areas of Regulatory, Quality or compliance and have an interest and knowledge of the area of pharmaceutical regulatory affairs.

Responsibilities
  • Subject matter expert within Global Regulatory Affairs (GRA), responsible to provide expertise and oversight for all CMC regulatory aspects and activities related to the assigned product(s), including as applicable:
  • Definition and execution of effective CMC regulatory strategies for product lifecycle management projects, post-approval CMC changes, CMC related health authority requests, and new license applications in additional countries.
  • Key partner and primary GRA point of contact for technical project management and relevant technical expert departments (e.g. Manufacturing, Quality Management, Supply Chain, Qualified Persons and R&D).
  • Preparation, revision and review of CMC related dossier components (e.g. Module 2.3, Module 3, and response documents).
  • Maintenance of compliant CMC core dossiers in accordance with current standards.
  • Appropriate planning, prioritization and preparation of CMC related submissions in close collaboration with relevant GRA sub-functions as well as Regulatory Affairs personnel or other relevant counterparts at license partners and CMOs.
  • Represent Regulatory Affairs CMC in relevant Regulatory Affairs Strategy Team(s) (RAFT(s)) and cross-functional teams (e.g. Technical Teams).

Qualifications
  • Minimum Requirements
  • MA/MS or equivalent university degree in natural or life sciences
  • Sound knowledge in natural sciences.
  • Fluency in English (verbal and written).

Additional Qualifications
  • Ph.D. or further degree, e.g. in Regulatory Affairs
  • Experience in Regulatory Affairs, Quality, Pharmaceutical Development or other relevant area in the biotech or pharmaceutical industry.
  • Good command of local language (verbal and written).

About Us

The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

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Date limite: 08-06-2024

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