Technical Associate Reg. Affairs

Year    Mumbai, Maharashtra, India

Job Description





With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world\xe2\x80\x99s biggest brands\xe2\x80\x94and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We\xe2\x80\x99re harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we\xe2\x80\x99re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.
Welcome to the relentless pursuit of better.


Inviting applications for the role of TA, Publisher!


The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian Submissions.
Performing final technical quality review.
Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders; Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
Qualifications we seek in you!
Minimum qualifications


B. Pham/M.Pharm/Science Graduate
In depth working knowledge of ECTD types of submission, industry standard publishing systems.
Effective time management and organizational skills
Effectively communication
Flexibility to adapt to a changing environment Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.


Preferred Qualifications Experience in Pharmacy Regulatory Affairs


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 diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter , Facebook , LinkedIn , and YouTube .
Job
Technical Associate Primary LocationIndia-Mumbai ScheduleFull-time Education LevelBachelor\'s / Graduation / Equivalent Job PostingApr 12, 2023, 2:25:13 AM Unposting DateOngoing Master Skills ListOperations Job CategoryFull Time

Beware of fraud agents! do not pay money to get a job

MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.


Related Jobs

Job Detail

  • Job Id
    JD3056700
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Mumbai, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year