Regulatory Affairs Officer

1 week ago

Bengaluru Karnataka, India IQVIA Full time

Job Overview
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.

Essential Functions
- Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
- Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
- Understands the Scope of Work, deliverables for any given project;
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
- May prepare and deliver trainings, as appropriate;
- Performs other tasks or assignments, as delegated by Regulatory management;
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;

Qualifications
- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- Master's Degree Degree in Lifescience or related discipline Req
- At least 2 years relevant experience
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
- Good, solid interpersonal communication (oral and written) and organisation skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Demonstrates self-motivation and enthusiasm;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

  • regulatory affairs

    2 weeks ago

    Bengaluru, Karnataka, India Randstad MENA Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Job Description Job Details This job offer closes 6 January 2026.SummaryLocation: Bengaluru, Karnataka Company: A client of Randstad India Type: Temporary Posted on: 7 November 2025 Reference Number: JPC Next StepsContact the recruiter Set a job alert Create an account Search jobs Randstad Professional We bring diverse and...

  • Regulatory Affairs Manager

    1 week ago

    Bengaluru, Karnataka, India Kumar Organic Products Full time

    Job Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...

  • International Regulatory Affairs Manager I

    3 days ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in...

  • Regulatory Affairs

    2 weeks ago

    Bengaluru, Karnataka, India MM Staffing & Career Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description:Job SummaryThe Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all...

  • regulatory affairs

    2 weeks ago

    bengaluru, India Randstad Full time

     What do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...

  • Reg Affair Officer

    4 days ago

    Bengaluru, Karnataka, India IQVIA Full time

    Role Summary: We are seeking a qualified Regulatory Affairs Project Coordinator and manage outsourced local regulatory affairs activities across multiple international markets. The role involves coordinating regulatory submissions, artwork workflows, database updates, and compliance tracking, ensuring alignment with global standards and internal SOPs. Key...

  • Regulatory Affairs Executive

    2 weeks ago

    Bengaluru, Karnataka, India INVISION PHARMA LIMITED Full time

    **Role Summary** **Key Responsibilities** - Prepare and submit product dossiers, licenses, and renewals to FSSAI/AYUSH/CDSCO as per nutraceutical guidelines. - Ensure product labeling, packaging, and claims comply with regulatory requirements. - Coordinate with R&D, QA, QC, and Marketing teams to ensure timely product launches. - Track and implement changes...

  • Regulatory Affairs Manger 1 Bengaluru, Karnataka, India

    2 weeks ago

    Bengaluru, Karnataka, India AstraZeneca Full time

    **Location** Bengaluru, Karnataka, India **Job ID** R-229249 **Date posted** 24/06/2025 **Job Title: Regulatory Affairs Manager I** **Introduction to role** Are you ready to lead the charge in regulatory affairs and make a significant impact in the biopharmaceutical industry? As a Regulatory Affairs Manager I, you'll be at the forefront of planning,...

  • Regulatory Affairs Associate

    1 week ago

    Bengaluru, India Parexel Full time

    **_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...

  • Junior Regulatory Affairs Associate

    6 days ago

    Bengaluru, Karnataka, India Parexel Full time

    **Key Accountabilities**: **Project Administration**: - Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. - Provide...