Lead Associate – Regulatory Affairs Operations
Location: Mumbai, India (Remote/Hybrid flexibility may apply)
Employment Type: Full-Time
Education Required: Bachelor’s Degree in Pharmacy, Life Sciences, Medicine, or Chemistry
Experience Required: 2–5 years in regulatory affairs or publishing roles in pharmaceuticals
Job ID: LIF022775
About Genpact
Genpact (NYSE: G) is a global leader in advanced technology services, delivering AI, automation, and digital solutions that transform enterprise operations worldwide. Through cutting-edge innovations, deep domain knowledge, and operational excellence, Genpact helps businesses across industries work smarter, grow faster, and achieve sustainable success. Our teams leverage data, technology, and AI to solve complex challenges and drive measurable business impact. Learn more at genpact.com and follow us on LinkedIn, YouTube, and X.
Role Overview
We are seeking a Lead Associate – Regulatory Affairs Operations to join our global team. The ideal candidate will have strong knowledge of ICH guidelines, CTD/eCTD submissions, and industry-standard publishing tools such as Liquent, DocuBridge, and related systems. You will play a critical role in managing regulatory submission publishing, ensuring compliance, and maintaining high-quality standards for US and global submissions.
This role is ideal for professionals with hands-on regulatory publishing experience seeking to grow their expertise in a global, technology-driven environment.
Key Responsibilities
Execute end-to-end eCTD/CTD/NEES/paper submissions for US and global regulatory authorities.
Perform technical validation and final quality review of regulatory submissions.
Dispatch submissions to authorities or affiliates and ensure accurate tracking and acknowledgment.
Capture post-submission correspondence and metadata in Regulatory Information Management (RIM) systems.
Communicate submission status to key stakeholders and ensure compliance with ICH, FDA, and internal guidelines.
Maintain accurate records and ensure timely updates of commitments, correspondence, and submission tracking.
Collaborate with cross-functional teams including regulatory, clinical, and medical affairs to ensure high-quality deliverables.
Identify process improvements and contribute to efficient submission management practices.
Qualifications & Experience Required
Mandatory:
Bachelor’s degree in Pharmacy, Medicine, Chemistry, or related Life Science discipline.
Strong understanding of ICH guidelines and CTD/eCTD structure.
Experience with regulatory publishing tools such as Liquent, DocuBridge, or similar systems.
Excellent written and spoken English communication skills.
Proven ability to manage multiple regulatory submissions and meet deadlines in a fast-paced environment.
Preferred:
2–5 years of experience in regulatory affairs or regulatory publishing within the pharmaceutical industry.
Knowledge of FDA, US market submissions, and global regulatory requirements.
Ability to adapt to dynamic, technology-driven workflows and work collaboratively across teams.
Familiarity with post-submission processes, RIM systems, and metadata management.
Key Attributes:
Strong attention to detail and organizational skills.
Time management and prioritization skills.
Enthusiasm, confidence, and proactive problem-solving mindset.
Commitment to quality and regulatory compliance.
Why Join Genpact?
Drive Transformation: Work with AI, automation, and digital innovation to shape the future of regulatory affairs.
Career Growth: Access mentorship, training, and global exposure to advance your career.
Global Impact: Contribute to regulatory compliance and submissions for leading pharmaceutical enterprises worldwide.
Inclusive Culture: Join a team guided by integrity, respect, and collaboration.
Competitive Benefits: Comprehensive compensation package including health coverage, paid leave, and career development support.
Equal Opportunity Statement
Genpact is committed to creating an inclusive and diverse workplace. We consider all applicants without regard to race, color, religion, sex, age, national origin, citizenship status, marital status, veteran status, disability, sexual orientation, gender identity, or any other characteristic protected by applicable law.
Note: Genpact does not charge any fees for job applications or hiring. Be alert for scams requesting payment or equipment purchase.
Apply Now to become a part of Genpact’s global regulatory operations team and advance your career in regulatory affairs.
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Auckland |New Zealand :
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Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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