Lead Associate – Regulatory Affairs - Bengaluru / Bangalore - confidential

    confidential
    confidential Bengaluru / Bangalore

    1 week ago

    Full time Sales
    Description
    Ready to shape the future of work
    At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge.

    Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale.

    From large-scale models to agentic AI, our breakthrough solutions tackle companies' most complex challenges.

    If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.

    Genpact (


    NYSE:
    G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally.

    Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead.

    Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at and on LinkedIn, X, YouTube, and Facebook.

    Inviting applications for the role of Lead Associate, Publisher for US market - Regulatory Affairs- Operations

    In this role, You should be fresher or minimum years of experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.

    Responsibilities
    .The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to.
    .Submission Publishing and performing final technical quality review and technical validation (eCTD) for Canada and US submissions.
    .Should have knowledge about MAA, NDS, ANDS, IND, DMF, NDA, ANDA and BLA submissions e.g. Safety Submissions, Annual reports, OPDP submissions, Protocol and amendment, original application.
    .Notifying relevant stakeholders that the Submission is ready for approval
    .Dispatching submission to CESP, EMA, HC and US FDA.
    .Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt capturing and the electronic receipt and metadata in RIM communicating submission receipt to key stakeholders.
    .Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics informing future planning and forecasting activities supporting overall regulatory intelligence
    Qualifications we seek in you
    Minimum Qualifications
    .Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
    .Mandatory Knowledge of ICH, FDA and EMA guidelines.
    .Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
    .Should be advance level in English language.
    .In depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
    .In depth working knowledge of industry standard publishing systems and desktop applications.
    .Expertise with Publisher applications
    .Effective communication, time management and organizational skills.
    .Technical Trouble shooting
    .Flexibility to adapt to a changing environment,
    .Demonstrated project management and leadership skills.
    .Skilled at fostering customer relationships and driving collaboration.
    .Understanding of global regulatory processes and requirements.
    .Strong attention to detail, ability to multi-task.
    .Expertise with industry standard electronic document management system

    Preferred Qualifications/ Skills
    Key Attributes
    .Enthusiasm & confidence
    .Adhere to our principles and values.
    .Time Management skills.
    Why join Genpact
    .Be a transformation leader - Work at the cutting edge of AI, automation, and digital innovation
    .Make an impact - Drive change for global enterprises and solve business challenges that matter
    .Accelerate your career - Get hands-on experience, mentorship, and continuous learning opportunities
    .Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
    .Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

    Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.

    Let's build tomorrow together.

    Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws.

    Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.

    Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way.

    Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training.
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