[Hiring] Senior Associate - Regulatory Affairs - Operations @BrightClaim

Role Description

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

• Minimum of 3 years of experience in regulatory affairs with 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.
• Advanced level in English language.

Requirements

• 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 and troubleshoot problems that arise within job responsibilities and expectations.
• 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.

Benefits

• 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.