[Hiring] Specialist - Regulatory Affairs - Operations @BrightClaim

Role Description

In this role you will be responsible for:

• Publishing and performing technical validation of eCTD for US submissions.
• Performing final technical quality review.
• Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority.
• Performing post-submission processing activities such as receiving acknowledgement from 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.

Qualifications

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

Requirements

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
• Mandatory Knowledge of ICH and FDA guideline for US market.
• Working knowledge of eCTD/CTD/NEES types of submission, industry standard publishing systems.
• Should be advanced level in English language.
• In-depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
• Effective time management and organizational skills.
• Effective communication.
• Flexibility to adapt to a changing environment.

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.