Vantive : A New Company Built On Our Legacy
Baxter is on a journey to separate our $5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve.
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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Summary :
The candidate will be directly responsible and accountable for global regulatory product ownership of pharmaceutical (drug) products.
Responsible for establishing RA strategy for and authoring of US and EU dossiers (CTD M1 M5), with heavy emphasis on Chemistry, Manufacturing, and Controls as well as drug product labeling.
The person will be instrumental to the design and definition of the Regulatory strategy for the products in the business unit.
Essential Duties and Responsibilities :
- Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses / authorizations for existing marketed products
- Author and lead preparation of submission deliverables and relevant CTD sections for US and EU drug product submissions, targeting first-pass approval from Health Authorities.
- Lead and support deliverable preparation / authoring for rest-of-world submissions for assigned drug product(s) for geographic expansion initiatives.
- Develop and document sound regulatory decisions and justification.
- Perform change control assessment consistent with global regulatory guidance
- Ensure global regulatory strategy and deliverables are aligned with project teams and business objectives
- Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
- Communicate with regulatory authorities
- Represent or lead the RA function on assigned cross-functional project teams
- Establish appropriate, proactive communication within RA, with GBU Marketing, and with other functions primarily at project level
- Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans
- Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
- May review SOP’s for compliance with global regulations
- May represent Baxter interests in industry and working groups
Qualifications :
- Demonstrated success in previous US drug regulatory product lead role with strong experience in RA CMC / drug product labeling
- Scientific knowledge
- Ability to multitask and prioritize
- Ability to work effectively in multinational / multicultural environment
- Project Management skills
- Ability to manage complex projects and timelines in a matrix team environment
- Demonstrated interpersonal skills including strong negotiation skills
- Technical and management skills
- Ability to independently identify compliance risks and escalate when necessary
Education and / or Experience :
Bachelor’s degree or country equivalent in a scientific discipline
Masters and / or PhD will be an advantage.
Minimum of 5-year drug regulatory experience in RA or related field, including managing people or projects.
Manager, Regulatory Affairs - Labeling (Hyderabad, India)
Manager, Regulatory Affairs - Labeling. Independently ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products, driving measurable efficiencies and continuous improve...
Senior Manager, Regulatory Affairs CMC (Onsite Hybrid)
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions....
Manager, Regulatory Affairs -Product Development & Post Approval
The Manager of Regulatory Affairs – Product Development and Post Approval serves as the primary regulatory interface with Partners and internal teams regarding Drug Product and Analytical method development and post-approval activities. Manager, Regulatory Affairs – Product Development a...
Project Manager (Quality/Clinical/Regulatory Affairs)
Project Manager (Quality/Clinical/Regulatory Affairs). The Project Manager provides project leadership for high-visibility, highly complex compliance initiatives across multiple business units and functions around the globe. This leader works closely with the program manager and project teams to def...
Manager, Regulatory Affairs
The candidate will be directly responsible and accountable for global regulatory product ownership of pharmaceutical (drug) products. The person will be instrumental to the design and definition of the Regulatory strategy for the products in the business unit. Develop and execute regulatory plans al...
Regulatory Affairs Manager
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applicatio...
Senior Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics (Remote)
Support the development of the device regulatory strategy and provide device input into the preparation and maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the...
Manager, Regulatory Affairs
The Manager position in Regulatory Affairs contributes to the regulatory strategy for new and modified Sysmex medical device products. The Manager Regulatory Affairs is responsible for the preparation, documentation and submission of regulatory applications for Sysmex products. We currently have a g...
Regulatory Affairs Documentation Manager
Responsible for interacting with government regulatory agencies (such as FDA, USDA, and international agencies as necessary) regarding registration processes for procedures requiring regulatory approval. Directly manages the International Regulatory Affairs Specialists. Prepares and submits internat...
Regulatory Affairs Manager II
The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standa...