Welcome to the relentless pursuit of better.
The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment.
Inviting applications for the role of Senior Manager, Publishing (Submission & Document Publishing)!
- 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.
Qualifications we seek in you!
- 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
- Effectively communication
- Flexibility to adapt to a changing environment.
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: Senior Manager
Primary Location: India-Mumbai
Education Level: Bachelor’s / Graduation / Equivalent
Keywords: Genpact Regulatory Affairs, Job Opening, Pharma Candidates, Submit Online. Genpact Regulatory Affairs Vacancy For Pharma Candidates, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.