Carrières

Responsibilities:

The Regulatory Affairs Project Manager/Snr Manager (RA-PM) is responsible for managing US FDA submissions including all aspects of planning and project management to deliver successful high-quality on-time submissions. The RA-PM works cross functionally with US and Global team members, assisting in document preparation and ensuring compliance with internal SOPs and FDA requirements and proactively identifies any regulatory risks. The RA-PM plays a key role in supporting US regulatory strategies for Vifor products whether in research and development or in post-marketing.   

Tasks:

Project Management for US Regulatory Submissions

• Assist or take the lead in tracking, authoring, coordinating all aspects of submissions for Vifor NDAs, INDs and BLAs including supplements, amendments, pediatric plans, annual or other periodic reports and advertising/promotional materials.
• Interface and collaborate with a diverse group of content authors to discuss planned submission preparation and ensure that documents comply with regulatory and company guidance/template specifications.
• Support post approval product maintenance and regulatory compliance through accurate Regulatory Information Management
• Provide oversight of regulatory consultants and publishing vendors supporting US regulatory submissions where applicable.

Support US Regulatory Strategy

• Provide support to the US regulatory lead(s) in all aspects of regulatory affairs.
• Critically review documents for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs.
• Assist or serve as the US Regulatory representative on project teams, manage regulatory timelines, and provide strategic input.
• Conduct research and review of guidelines, regulatory precedence, and competitive intelligence to facilitate development of regulatory strategy.
• Assist the US regulatory lead in FDA interactions and meetings

Continuous improvement

• Monitor and maintain up-to-date knowledge of laws, regulations, and policies enforced by the FDA as they relate to submissions, labeling, advertising, and promotion of pharmaceuticals; provide regulatory advice and updates internal stakeholders accordingly.
• Work with other regulatory team members (US and Global) to provide input into improvement of systems and/or processes, including support for the development of department SOPs/processes.
• Provide training and knowledge sharing on regulatory processes.

Qualifications:

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:

Minimum Requirements

• Bachelor's degree in pharmacy, life sciences, nursing, or equivalent. 
• 1 to 3 years of regulatory affairs relevant experience. Minimum of 2 to 5 years total relevant industry experience.
• Experience with the use of document management systems (e.g. eDMS, OpenText Documentum or Veeva).
• Knowledge of eCTD submissions and standards to FDA.
• Experience in use of Regulatory Information Management Systems (e.g. LifeSphere RIMS, Veeva)

Preferred Requirements

• Master’s degree, PharmD, or other advanced degree is preferred.
• Knowledge of relevant therapeutic areas (renal, cardiovascular) is desirable.