Regulatory Affairs Associate Ii

3 weeks ago

Bengaluru, India Whatjobs IN C2 Full time

Role: Regulatory Affairs Associate II Work location: Mumbai & Bangalore Summary: The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions—including original applications, amendments, deficiency responses, and post-approval supplements—while collaborating closely with cross-functional teams. The role includes evaluating change controls, determining appropriate regulatory pathways (e.G., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives Job responsibilities: With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gaps. Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways. Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements. Track regulatory guidance updates, stay current with evolving regulatory requirements. Monitor relevant FDA databases (e.G., , Orange Book) and ensure internal stakeholders are informed of critical changes. Participate in audits, inspections, and process improvement initiatives. Experience & Qualification: Master’s degree in RA/QA discipline, preferably in Pharma. Minimum 4+ years pharmaceutical industry experience with inhalation, implant, ophthalmic, and drug-device combination products; Regulatory, Analytical, QA, laboratory or production experience preferred. Demonstrates an understanding of ICH and FDA guidelines Demonstrates excellent verbal and written communication skills. Demonstrates excellent organization skills and the ability to multi-task; detail oriented. Possesses strong critical and logical thinking. Best regards Ankita

  • Regulatory Affairs Associate

    4 days 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...

  • Regulatory Affairs Associate

    1 week ago

    Bengaluru, India Antal International Full time

    Job Description **Job Title**: Regulatory Affairs Associate **Department**: Regulatory Affairs and Quality Compliance **Position at**: Bangalore **Position’s Objective & Summary**: Self-starter, executes the Regulatory strategy for obtaining registration approval of the company portfolio, according to plan. With limited supervision, coordinates and...

  • regulatory affairs

    7 days 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 Associate

    2 weeks ago

    Bengaluru, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

  • Regulatory Affairs Manager

    4 days 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...

  • Manager - Regulatory Affairs

    4 weeks ago

    Bengaluru, India Aarna Hr Solutions Full time

    Job Description We are seeking a highly experienced and meticulous Manager - Regulatory Affairs to oversee and execute all regulatory activities for drug substances and products. The ideal candidate will be responsible for the preparation, submission, and management of various regulatory documents, ensuring compliance with global regulatory agencies. This...

  • Regulatory Affairs

    7 days 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 Professional

    6 days ago

    Bengaluru, India Siemens Healthineers Full time

    Siemens Healthineers is looking for a Regulatory Affairs Professional for its medical imaging portfolio. **Role/Internal Title**: Regulatory Affairs Professional **Business Title**: Deputy General Manager **Role Summary** - Lead and spearhead the Regulatory compliance requirements of Pre-Conception and Pre-Natal Diagnostic techniques and ensure compliance...

  • regulatory affairs

    1 week 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...

  • Regulatory Affairs

    1 week ago

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

    Note- Candidates who can join immediately can apply Job Description -Regulatory Affairs- Intern Overview We are seeking a highly motivated and experienced person to join our team Responsibilities:Participate in the development of regulatory submission and approval strategy in multiple countries.Maintain awareness and understanding of new and existing...