Senior Specialist – Regulatory Affairs
Location: Bengaluru, Karnataka, India
Job Category: Regulatory Affairs
Job ID: JR-191963
Experience Required: Minimum 2 years in regulatory affairs within pharmaceutical, medical device, or CRO environments
Company Overview
Vantive is a leading vital organ therapy company dedicated to extending lives and transforming patient care worldwide. With over 70 years of innovation in kidney care, Vantive combines advanced therapies with digital solutions to improve the dialysis experience and invest in broader vital organ therapy advancements.
Joining Vantive means contributing to a mission-driven environment where excellence, innovation, and patient outcomes are at the forefront. You will collaborate with a passionate team focused on delivering meaningful impact in healthcare globally.
Role Overview
As a Senior Specialist in Regulatory Affairs, you will support the implementation of global regulatory strategies, manage marketing authorizations, and ensure compliance with regional and international regulatory requirements. This role offers the opportunity to contribute to regulatory planning, execution, and guidance across Vantive’s product portfolio, ensuring high-quality submissions and approvals.
You will work under limited supervision and act as a regulatory advisor within project teams, supporting regulatory decision-making and maintaining compliance across all assigned projects.
Key Responsibilities
Develop, implement, and execute regulatory project plans for assigned products/projects.
Identify regulatory risks and escalate when necessary, ensuring proactive mitigation.
Maintain awareness of global regulatory requirements and monitor updates in the pharmaceutical and medical device sectors.
Compile, review, and submit regulatory documents to authorities in accordance with established timelines.
Maintain and update regulatory files and marketing authorizations.
Prepare, review, and approve product labeling and Standard Operating Procedures (SOPs).
Provide regulatory guidance and advice to cross-functional project teams.
Represent Regulatory Affairs in small project teams and support strategy discussions.
Respond to regulatory authority queries promptly and professionally.
Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or equivalent.
Experience:
Minimum 2 years of regulatory affairs experience within pharmaceutical, medical device, or CRO environments.
Knowledge of European and/or US post-approval regulatory requirements (variations, CBE/PAS).
Experience in preparing submissions, maintaining regulatory files, and managing product authorizations.
Skills & Competencies:
Strong understanding of global regulatory frameworks and compliance requirements.
Scientific knowledge related to pharmaceuticals and medical devices.
Project management capabilities; able to manage multiple priorities and deadlines.
Excellent interpersonal, communication, and negotiation skills.
Proficiency in technical systems: word processing, spreadsheets, databases, and online research.
Ability to identify compliance risks and escalate appropriately.
Why Join Vantive?
Vantive offers a dynamic and inclusive work environment, empowering employees to innovate and make a tangible impact in patient care. You will gain exposure to global regulatory processes and collaborate with cross-functional teams to drive excellence in regulatory compliance and product approvals.
Vantive is committed to providing reasonable accommodations to individuals with disabilities and fostering a safe, inclusive workplace globally.
Apply today to join Vantive and advance your career in regulatory affairs while contributing to innovations that improve patient lives.
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