Specialist, Regulatory Affairs

3 weeks ago


bangalore, India Baxter Full time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Create and Review regulatory documentation for Drug, Device and Combination product renewals. Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals Track status and progress of regulatory documentation that will be used for renewals Coordinate and compile responses to regulatory authority renewal questions (under supervision) Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities Answer internal queries for assigned products Maintain Database of Regulatory Requirements for renewals Knowledge of regulations Scientific knowledge Administrative and project management skills Ability to contribute to multiple projects from a regulatory affairs perspective Ability to multitask and prioritize Interpersonal and communication skills Technical system skills (e.g. word processing, spreadsheets, databases, online research) Proofreading and editing skills Ability to independently identify compliance risks and resolve or escalate as necessary

  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Associate I Career Level - C Introduction to Role: Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role is an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager II  Career Level - D Introduction to Role: Join our International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients in international markets as efficiently and effectively as possible. We have an exciting opportunity for a Regulatory Affairs Manager...


  • Bangalore, India AstraZeneca Full time

    Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business...


  • bangalore, India AstraZeneca Full time

    Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and...


  • bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...


  • bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...


  • Bangalore, India AstraZeneca Full time

    Job Title: iCMC Regulatory Affairs Manager Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as an iCMC Regulatory Affairs Manager. This is an exciting opportunity to innovate in a safe environment, where you will be part of a team with deep specialist knowledge and regulatory expertise. We are confident in what we know...


  • bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be responsible...

  • Regulatory Specialist

    4 weeks ago


    bangalore, India Novo Nordisk AS Full time

    Department : RA Labelling Are you passionate about ensuring regulatory compliance and driving high-quality global packaging materials? Do you have expertise in labelling and project management? We are looking for a Regulatory Specialist to join our team in Bangalore and be part of our global Regulatory Affairs (RA) hub. If you are ready for a...


  • Bangalore, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our dynamic International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients across the globe. We have an exciting opportunity for a Regulatory Affairs Manager I to contribute to our mission. In this role,...


  • bangalore, India Indegene Full time

    Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain...


  • bangalore, India Lifelancer Full time

    About the job Job Description Summary This position is responsible for the creation, identification, collection, and entry of regulatory affairs information of medical devices. Support related regulatory affairs activities, such as assessment, execution and management of regulatory data and information to support all regulatory needs and objectives of...

  • Regulatory Specialist

    2 months ago


    bangalore, India Novo Nordisk Full time

    The position As a RA Specialist, the ideal candidate will be responsible to design RA Strategy from late stage development and throughout Life cycle of the device project, prepare and submit high quality files to the authorities achieving fast approvals. Act as an ambassador for assigned medical devices/device part of combination products. This...


  • bangalore, India ResMed Full time

    Summary: A Regulatory Affairs Administrative Assistant provides essential support to regulatory affairs professionals in managing compliance, documentation, and administrative processes. They play a crucial role in ensuring smooth operations within the regulatory department. Responsibilities and Accountabilities: Document Management: Assist in...

  • Regulatory Specialist

    4 weeks ago


    bangalore, India Novo Nordisk Full time

        Department : RA Labelling   Are you passionate about ensuring regulatory compliance and driving high-quality global packaging materials? Do you have expertise in labelling and project management? We are looking for a Regulatory Specialist to join our team in Bangalore and be part of our global Regulatory Affairs (RA) hub. If you are ready for a...