Senior Regulatory Affairs Associate

2 weeks ago


Bengaluru, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Must have 4-6 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) Strong knowledge of US, EU, Switzerland, Canada and, Australia regulatory labeling lifecycle management The ability to research and create comparator labeling documents. Strong understanding and experience creating annual reports. The ability to collaborate with Tech Ops for artwork implementation. Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. Managing label updates, compliance, and governance. Electronic document management systems use and / or electronic submission experience. Life Cycle Management, Post Approval Labeling submissions including PSUR submissions. Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging. Monitor, manage and control artwork changes. To manage and maintain the Artwork Trackers & Systems. To ensure artwork PDF’s are maintained and latest versions are readily available. Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved Experience with consumer advertising and educational materials Experience in handling Veeva, TVT, Docubridge etc.

  • 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...


  • 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...


  • Bengaluru, India Biocon Biologics Full time

    Job Description We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: Plan and manage development of high...


  • Bengaluru, India ITC Full time

    Regulatory Affairs Manager ITC Foods Location: Bangalore Experience: 10+ years We are looking for a seasoned Regulatory Affairs Manager to join our team at ITC Foods. Key Responsibilities: Lead regulatory compliance for food products across the US (FSMA, 21 CFR, USDA including NOP), EU, GCC and other international markets which includes Regulatory and Food...


  • Bengaluru, India Biocon Biologics Limited Full time

    JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high...


  • Bengaluru, Karnataka, India AliveCor Full time US$ 1,00,000 - US$ 1,50,000 per year

    DescriptionAt AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered...


  • 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

    4 weeks ago


    Bengaluru, India Surgeway Biosciences Private Limited Full time

    JOB TITLE :Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria) WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES? As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training...

  • Regulatory Affairs

    1 week ago


    Bengaluru, Karnataka, India Surgeway Biosciences Private Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    JOB TITLE :Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training...


  • Bengaluru, India Biocon Biologics Full time

    Job Description Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings...