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(Sr.) Manager, Regulatory Affairs

Salary undisclosed

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Position Overview:
We are seeking a highly skilled and result-driven Regulatory Affairs Professional to lead our regulatory initiatives in Singapore and SEA. The successful candidate will be responsible for developing and executing regulatory strategies, ensuring compliance with local and international regulations, and facilitating the approval of our innovative products.Key Responsibilities:
  • Develop and implement regulatory strategies for product submissions and product lifecycle management, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and marketing authorizations.
  • Prepare and submit high-quality regulatory documentation to local health authorities and international regulatory bodies.
  • Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure compliance throughout the product lifecycle.
  • Serve as the primary liaison with regulatory authorities, managing inquiries and negotiations effectively.
  • Monitor and interpret changes in regulations, guidelines, and industry standards, providing insights and recommendations to the organization.
  • Conduct regulatory risk assessments and develop mitigation strategies to address potential compliance issues.
  • Provide training and guidance to internal teams on regulatory requirements and best practices.
Qualifications:
  • Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
  • Minimum 3-5 years of experience in regulatory affairs within the pharmaceutical industry
  • Strong knowledge of local and international regulatory requirements, including FDA, EMA, and Health Sciences Authority of Singapore (HSA) guidelines.
  • Proven track record of successful regulatory submissions and approvals.
  • Excellent communication, negotiation, and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and manage multiple projects simultaneously.
  • Singapore Registered Pharmacist is a plus.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional development and career advancement.
  • A warm, flexible, dynamic and collaborative work environment.