Job Description

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it.
Transformation happens here. Come, be a part of our exciting journey!
Are you the one we are looking for?
Inviting applications for the role of Manager, Submission Manager!
Responsibilities
The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to

• Managing 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

• B. Pham/M.Pharm/Science Graduate
• Experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, Extedo,etc.
• 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

• Pharmacy