Principal Specialist, Regulatory Affairs

Baxter

10+ years

Not Disclosed

Bangalore

10 Sept. 23, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Vantive: A New Company Built on Our Legacy

Baxter is embarking on an exciting journey to separate our approximately $5B Kidney Care segment into a standalone company, Vantive. With nearly 70 years of expertise in acute therapies and dialysis—both home and in-center—Vantive is poised to deliver exceptional care to those we serve. We aim to strengthen our leadership in the kidney care field and provide meaningful opportunities for those who join our mission.

At Vantive, you will become part of a dedicated community of individuals who are focused, courageous, and committed to excellence. Together, we strive to enhance patients' lives globally. Join us as we revolutionize kidney care and vital organ support.

Note: The completion of this separation is subject to the satisfaction of customary conditions.

Position Summary

We are seeking a Regulatory Affairs professional responsible for implementing complex global regulatory strategies, obtaining and maintaining marketing authorizations for our products, and communicating general regulatory requirements to support product licensing. This role will serve as a consultant to management and oversee regulatory activities for a specific global portfolio of products/projects. Initially, the focus will be on post-marketing regulatory activities, particularly in coordinating regulatory impact assessments for changes and preparing subsequent variations.

Essential Duties and Responsibilities

Develop and initiate complex regulatory project plans.
Identify and prioritize key regulatory risks.
Monitor applicable regulatory requirements to ensure compliance.
Create and maintain regulatory files in accordance with industry standards.
Provide regulatory guidance to project teams.
Respond to complex inquiries from regulatory authorities within strict timelines.
Compile and submit regulatory documents promptly in compliance with requirements.
Maintain and update existing regulatory authorizations.
Oversee regulatory activities for a designated portfolio of products/projects.
Prepare, review, and approve labeling and standard operating procedures (SOPs).
Lead or represent Regulatory Affairs in project teams.
Mentor and coach junior team members in areas of responsibility.

Qualifications

In-depth knowledge of regulatory standards and guidelines.
Strong scientific background.
Proven project management skills, with the ability to manage multiple projects and deadlines.
Excellent multitasking and prioritization abilities.
Strong interpersonal and communication skills.
Effective negotiation skills.
Proficient in technical systems (e.g., word processing, spreadsheets, databases, online research).
Ability to work effectively in a multinational and multicultural environment.
Capability to identify compliance risks and escalate issues as necessary.

Education and Experience

Bachelor’s degree or equivalent in a scientific discipline.
Minimum of 10 years of regulatory experience or equivalent in the pharmaceutical and/or medical device industry, CRO, or similar organization.

Reasonable Accommodations

Vantive is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance during the application or interview process due to a medical condition or disability, please click here to inform us of your needs along with your contact information.

Recruitment Fraud Notice

Vantive has identified incidents of employment scams where fraudulent parties impersonate Baxter employees or recruiters to obtain personal or financial information. To protect yourself, please review our Recruitment Fraud Notice.

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