Genpact Regulatory Affairs Job For Pharma
With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and 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’re 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’re 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.
Job Posting: Senior Manager, Publishing (Submission & Document Publishing)
The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment.
- Candidate should have extensive experience in the respective field.
- Technical expert on submissions
- Proven capability to manage the operations and team.
- Taking care of administrative responsibilities of team
- Project & resource management
- Team management and team engagement
- Should be technical expert in eCTD/CTD submissions of US/EU/Canada and Row market.
- Hands on experience on submissions
- Capability to trouble shoot technical validation errors.
- Good client communication skills
- Flexible attitude
- Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for Asia pacific, Europe Submissions and US 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 acknowledgement 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.
- Co-ordinate with client/stakeholders.
Minimum Qualifications: B. Pham/M.Pharm/Science Graduate
Preferred Qualifications/ Skills
- Technical Expert on submissions and document publishing
- Proven skills to Manage team and resources.
- Handled a direct team of publishers.
- In depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
- Effective time management and organizational skills
- Effective communication
- Flexibility to adapt to a changing environment.
Keywords: Genpact, Regulatory Affairs, Pharma, Senior Manager, Publishing, Submission, Document Publishing, Mumbai, Technical Expert.