Sr. Manager - Reg. Affairs
- Genpact India
- 5 to 11 Yrs
- Mumbai
- 4 years ago
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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 Senior Manager, Publisher
The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment.
Responsibilities
Manage the operations and team
Take care of administrative responsibilities of team
Project & resource management
Team management and team engagement
Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific, Europe Submissions, and US submissions
Perform final technical quality review.
Dispatch submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority
Perform post-submission processing activities such as receiving acknowledgment from the 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
Minimum qualifications
B. Pham/M.Pharm/Science Graduate
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
Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.
Should be a technical expert in eCTD/CTD submissions of US/EU/Canada and Row market
Hands-on experience on submissions
Capability to troubleshoot technical errors
Good client communication skills
Flexible attitude
Preferred Qualifications
Proven rich 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.
,Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: HRFunctional Area: Not ApplicableRole/Responsibilies: Sr. Manager - Reg. AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
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Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...
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