Senior Specialist Regulatory Affairs

7 days ago

Bengaluru, Karnataka, India Vantive Full time US$ 80,000 - US$ 1,40,000 per year

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 don't 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 Vantive's 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 SOP's
  • 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
Bachelor's 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

Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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