Senior Specialist Regulatory Affairs

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years our team has driven meaningful innovations in kidney care. As we build on our legacy we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams and longer fuller lives for patients that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space it will also offer meaningful work to those who join us. At Vantive you will become part of a community of people who are focused courageous and dont settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary

Under limited supervision responsible for the implementation of global regulatory strategies obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Vantives products. Support regulatory activities relating to specific portfolio of global products/projects.

Essential Duties and Responsibilities:

With direction develop and execute regulatory project plans
Identify and elevate key areas of regulatory risk
Maintain awareness of regulatory requirements; identify relevant requirements
Maintain regulatory files in a format consistent with requirements
Participate as an active team member and provide regulatory advice to project teams as required
Respond to questions from regulatory authorities within strict timelines
Compile and submit in a timely manner regulatory documents according to regulatory requirements
Maintain and update existing regulatory authorizations
Support regulatory activities relating to specific portfolio of products/projects
Prepare review and approve labeling and SOPs
Represent or lead Regulatory Affairs in small project teams

Qualifications

Knowledge of regulations. Experience dealing with European and/or US post approval regulations (variations CBE/PAS).
Scientific knowledge
Project management skills
Manage multiple projects and deadlines
Ability to multitask and prioritize
Interpersonal and communication skills
Negotiation skills

Technical system skills (e.g. word processing spreadsheets databases online research)
Ability to identify compliance risks and escalate when necessary

Education and/or Experience

Bachelors degree or country equivalent.
Minimum of 2-year regulatory or equivalent experience within a pharmaceutical and/or medical device company CRO or similar organization

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information. Form Link

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