Regulatory Affairs Manager

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.

Position Title:             RA Manager, Drug Project and RI

Report to:                    Head of RA, Drug Project and RI

Responsibilities:

• Develop and execute regulatory strategies for multiple complex programs and platforms related to local manufacturing projects as well as import drug projects according to responsible therapeutic areas.
• Develop and document sound regulatory decisions and justifications for assigned projects.
• Represent or lead cross-functional team on assigned projects.
• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
• Establish appropriate communication as internal as with cross functions primarily at project level, and also as external as with Health Authority.
• Response for assigned regulatory intelligence activity: monitor applicable regulatory requirements; assure regulatory compliance with external standards, perform gap analysis and remediation plan; policy interpretations and presentations to local and global colleagues.
• Response for assigned regulation & guideline shaping activity: develop external engagement activities with internal and external stakeholders, to build long-term and win-win relationship/partnership with external stakeholders.

Qualifications:

1.     Bachelor’s degree or above in Pharmaceutical related discipline.

2.     With minimum of 15 years’ work experience, incl. at least 5 years’ RA experience in MNC.

3.     Sound basis of Regulatory knowledge and Scientific Knowledge.

4.     Ability to manage complex projects and timelines in a matrix team environment and problem solving.

5.     Ability to insure projects on time delivery with high quality.

6.     Ability to independently identify regulatory strategy and risk with mitigation plan.

7.     Strong oral and written communication and presentation skills.

8.     Strong interpersonal skills incl. strong coordinate skills and experience in interacting with regulatory authorities.

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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