Regulatory Compliance Specialist for Pharmaceutical Industry

2 days ago


Dasmariñas, Calabarzon, Philippines Sydenham Laboratories Inc Full time

At Sydenham Laboratories Inc, we are seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a Regulatory Affairs Pharmacist, you will play a critical role in ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.

Key Responsibilities:

  • Staying up-to-date with changing regulatory requirements and guidelines in the pharmaceutical industry
  • Preparing and submitting regulatory documentation, including marketing authorisation applications and clinical trial applications
  • Liaising with regulatory authorities to address queries and secure approvals for our products
  • Providing regulatory guidance and support to research and development, manufacturing, and quality assurance teams
  • Maintaining comprehensive records and databases to track the regulatory status of our product portfolio
  • Identifying and mitigating potential regulatory risks to the business
  • Contributing to the development and implementation of regulatory strategies aligned with the company's commercial objectives

Requirements:

  • Pharmacy degree and valid registration as a pharmacist
  • Minimum 5 years' experience in a regulatory affairs role within the pharmaceutical industry
  • In-depth knowledge of regulatory requirements and guidelines in key markets
  • Excellent written and verbal communication skills, with the ability to liaise effectively with internal and external stakeholders
  • Strong attention to detail and problem-solving skills
  • Ability to work independently and as part of a cross-functional team
  • Proficiency in using regulatory information management systems and databases

About Us:

Sydenham Laboratories Inc is a leading player in the pharmaceutical industry, committed to delivering high-quality products and services. Our team is dedicated to excellence and innovation, and we are looking for talented individuals who share our vision and values.



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