Regulatory Affairs Coordinator FDF Portfolio

WHY THIS ROLE MATTERS

The Specialist, Regulatory Affairs FDF plays a pivotal role in ensuring that CENTRIENT’s pharmaceutical products meet global regulatory standards. This ensures patients worldwide have access to safe, effective, and high-quality medicines. The Specialist facilitates timely approvals and manages the lifecycle of product registrations, supporting cross-functional teams and enabling the company to maintain a competitive advantage in the global generic pharmaceutical market.

JOB DESCRIPTION

The Specialist supports the Regulatory Affairs team focusing on Finished Dosage Form (FDF) products. Responsibilities include preparing, submitting, and maintaining regulatory dossiers for global approvals. The role ensures compliance with international regulatory requirements, supports business objectives, and facilitates the lifecycle management of medicinal products.

The position combines administrative, technical, and strategic tasks, such as evaluating CMC data, preparing variation packages, responding to regulatory queries, and keeping documentation accurate and up to date. The Specialist also keeps the company informed of legislative and regulatory changes, contributing to continuous improvement in regulatory affairs.

KEY FEATURES OF THE ROLE

•Prepare, compile, and submit regulatory dossiers and variation packages for global registrations.
•Support lifecycle management of CENTRIENT products, ensuring compliance with regulations.
•Assist in pharmacovigilance activities and maintain product safety information.
•Evaluate CMC data to support submissions.
•Coordinate responses to regulatory authorities’ queries.
•Maintain and update product information texts.
•Stay updated on global regulatory legislation, draft guidelines, and best practices.
•Facilitate cross-functional alignment with Regulatory Affairs, Quality, Manufacturing, and Commercial teams.
•Contribute to SOP creation and review within the department.
•Maintain regulatory databases and track all RA activities.
•Escalate complex regulatory issues to senior RA staff.

RESPONSIBILITIES
•Collect and prepare regulatory dossiers and variation packages per business and regulatory requirements.
•Compile and update product dossiers for new registrations and lifecycle maintenance (NP and LCM).
•Assist in pharmacovigilance reporting and evaluation of safety and quality data.
•Review CMC data to support dossier submissions.
•Coordinate and draft responses to regulatory authorities.
•Create and maintain accurate product information, labels, and technical documents.
•Monitor global regulatory legislation, draft guidelines, and updates.
•Align cross-functionally with internal and external stakeholders.
•Support writing and implementing SOPs.
•Enter regulatory data into workplans and MA databases accurately.
•Ensure compliance with Master Data System (MDS) requirements.
•Escalate complex regulatory issues to senior RA staff.

REQUIRED QUALIFICATIONS

Educational Requirements:
•Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Biomedical-related field.
•Strong understanding of pharmaceutical sciences and regulatory processes.

Experience and Skills:
•3-5 years’ experience in Regulatory Affairs or relevant health registration environments, preferably in the generic pharmaceutical industry.
•Familiarity with global regulatory submissions, variation management, and lifecycle maintenance.
•Exposure to professional regulatory training programs preferred.
•Strong analytical, troubleshooting, and problem-solving skills.
•Excellent communication, collaboration, and English language skills.
•Accuracy, attention to detail, and creativity in regulatory documentation.

SALARY INSIGHTS

•Competitive, best-in-class compensation based on experience.
•Performance-based incentives and opportunities for global career growth.
•Benefits include professional development, learning opportunities, and a collaborative work culture.

COMPANY OVERVIEW

CENTRIENT is a leading global pharmaceutical company committed to delivering high-quality, affordable medicines worldwide. Operating in over 40 countries, CENTRIENT emphasizes innovation, regulatory compliance, and patient safety. The company promotes an inclusive, collaborative culture with opportunities to grow and make a meaningful impact in healthcare.

FAQS

Q: Is this role regional or global?
A: This is a global role, supporting regulatory submissions and compliance for CENTRIENT products worldwide.

Q: Will training be provided?
A: Yes, CENTRIENT offers extensive professional training in regulatory affairs and pharmaceutical compliance.

Q: What kind of products will I work with?
A: You will work with generic pharmaceutical Finished Dosage Form (FDF) products, supporting both new registrations and lifecycle management.

Q: Is travel required?
A: Occasional travel may be required but is minimal.

APPLICATION TIPS

•Highlight experience in regulatory submissions and dossier management.
•Demonstrate knowledge of global regulatory requirements and lifecycle management.
•Emphasize problem-solving, analytical, and cross-functional collaboration skills.
•Showcase accuracy and attention to detail in documentation.
•Include examples of successful regulatory approvals or variations managed in previous roles.