Sr. Associate - Regulatory Affairs - Operations 5B

About the role

Sr. Associate - Regulatory Affairs - Operations

Ready to turn bold ideas into real-world impact?

At Genpact, we don't just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we're at the forefront of it. Genpact's AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies' most complex challenges.

If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what's possible, this is your moment.

Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world's leading enterprises.

Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

About the role

Inviting applications for the role of Jr Manager, Regulatory Affairs for Translation management, artwork review and change management

In this role, you will be responsible for

• Ensure that changes required through DCIs are properly implemented in the SCF and that there are no differences against the approved artwork.
• Ensure that the changes in SCF are related to LRAM's DCI request, additional changes received in SCF comply with the regulation.
• In multi-country presentation, evaluate the impact of the changes to the countries involved. If applicable, align alternative solutions with the LRAMs of the affected countries.
• Develop the implementation plan together with the LCM.
• Utilization of software and systems like SAP, Veeva Vault, TVT
• Backup for the translation management activities
• Translation management activities for LATAM countries
• Coordination of dossier translation including retrieving and processing editable documents for translation
• Coordination of translation for maintenance events, renewals, CMC, CCDS
• Technical validation of received documentation and translated documents (including formatting, excluding subject matter/content check)
• Maintain traceability trackers

Qualifications we seek in you!

Minimum Qualifications

• You should have a minimum of 3 years of experience in regulatory affairs with must knowledge of current guidelines in LATAM Market.
• Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
• Mandatory Knowledge of Regulations for the LATAM market.
• Should be advance level in English language
• undefined

Preferred Qualifications/ Skills

• Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviours to drive high quality deliverables.
• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
• Depending on experience level, mentor newly hired staff or lead a team of junior staff.
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.

Qualifications

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs

Certifications

Certified Compliance Officer (CCO) - VskillsVskills, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

• Required Skills
• Personal Effectiveness
• Language
• English (Required)
• Language Proficiency -
• Beginner - A1
• Additional Job Location -
• Job Type
• Regular
• Master Skill List -
• Regulatory Affairs - Operations
• Remote Type -
• Remote
• Work Shift -
• Day Job (Costa Rica)