Regulatory Affairs Executive (PLMDS) Hiring at ClinChoice | Chennai

Regulatory Affairs Jobs ClinChoice | Chennai

ClinChoice, a leading global Clinical Research Organization (CRO), is actively hiring a Regulatory Affairs Executive (PLMDS) in Chennai. This role is ideal for candidates with a Bachelor’s/Master’s degree in Pharmacy or related fields and 2-4 years of experience in Regulatory Affairs, Quality Assurance, or R&D. If you’re ready to work for a world-renowned CRO, this opportunity is for you.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of industry expertise, ClinChoice has delivered high-quality results across more than 20 countries, employing 4,000+ professionals worldwide.

Position Overview: Regulatory Affairs Executive (PLMDS)

As a Regulatory Affairs Executive (PLMDS) at ClinChoice, you will play a crucial role in managing regulatory submissions and ensuring compliance with global health authorities. This is a client-facing role where you will provide operational support and collaborate with global stakeholders to deliver regulatory projects on time and with high quality.

Key Responsibilities

• Complete the assigned activities diligently, by using appropriate client specific standards and tools, confirming to regulatory submission milestones and applicable regulatory obligations.
• Provide operational support within the team to execute designated tasks associated with submission.
• Accountable for delivering designated submissions with quality and timely as per applicable  policy, SOP/Work, instructions, guidelines, or service level agreement.
• Commit to completing required on-the-job training courses to ensure training compliance is preserved.
• Continuous improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities.
• Support activities related to Product License Portfolio in a timely and quality manner.
• Execute the assigned activities to ensure completion of project tasks and/or milestones.
• Capable of understanding and implementing the basic team effectiveness skills like  commitment, feedback, trust, and teamwork.
• Apply necessary technical skills to complete the assigned regulatory operational activities to support submissions to global health authorities.
• Performs work in a structured environment under direction from supervisor.
• Exercises judgment to complete assigned tasks and has significant reliance on supervisor.
• Uses established procedures to perform assigned tasks.
• Participates and contributes as a team member and is responsible for certain team deliverables.

Qualifications and Experience

➔ Education: Bachelor’s/Master’s degree in Pharmacy or related fields such as Life Sciences or Regulatory Affairs.
➔ Experience: 2-4 years of experience in Regulatory Affairs, Quality Assurance, AR&D, R&D, or QC.
➔ Skills: Knowledge of regulatory submission tools like publishing systems, artwork, and change control management.
➔ Competencies: Strong decision-making abilities, adeptness with IT systems, and a quick learner with the ability to adapt to evolving demands.

Location

The position is based in Chennai, India

Application Process

Interested candidates who meet the qualifications are encouraged to apply by submitting their CVs through the official ClinChoice career portal