Spec, RA

Baxter

  • Ahmedabad, Gujarat
  • Permanent
  • Full-time
  • 3 days ago
This is where your work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a job—you will find purpose and pride.This position provide support to the Pharma RA team in review of technical documents and support in technical write-up needed for submission of high quality product dossiers in markets of US/EU/ANZ/Canada. The incumbent will perform other duties as assigned.
  • Support the regulatory team for obtaining and maintaining registration filings (ANDA/NDA for US; ANDS/NDS for Canada and national, MRP/DCP registrations i.e New MAAs, Extensions, Renewals, Supplements, Variations, Transfers of Ownership, etc.)
  • Review of technical documents like Specification/MOA/Stability protocol/Product Development report/Batch Mfg records, under supervision.
  • Work collaboratively with senior members of the team in activities such as high quality technical write-up/dossier authoring as per project requirements.
  • Collaborate with internal and external project team members for the collection, review and finalization of regulatory documents in a timely manner, under supervision.
  • Provide support as needed in any related regulatory activities.
  • Apply technical theories and principles to projects within area of expertise.
  • Work according to appropriate standards and Global practices (e.g., Data Integrity, E&C, GQPs) guidelines.
  • Maintenance of RA database for the responsible franchises in RIMS Tools.
  • Ensure uniformity, consistency and quality in the scientific and administrative content of the regulatory documents.
  • Disseminate the learnings and best practices at regular intervals across teams.
  • Capable of identifying when to ensure line support required to provide additional guidance and direction
  • Be a proactive member of the Regulatory team to ensure Baxter’s continuing compliance with regulatory authorities.
Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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 .

Baxter