Sr. Associate - Regulatory Affairs - Operations 5B

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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.

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Job Description

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

Responsibilities

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

Certifications

Required Skills

Language

Language Proficiency -

Additional Job Location -

Job Type

Master Skill List -

Remote Type -

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Why join Genpact?

• Lead AI-powered transformation - Drive innovation and solve real-world business challenges that matter
• Make an impact - Help global enterprises solve business challenges that matter
• Accelerate your career - Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
• Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
• Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up. Let’s build tomorrow together. 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 respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.