Regulatory Manager (Medicine) – 1,300,000 – Foreign Company

Team 18 (VAC)
Job Overview

Job Location: Mingalar Taungnyunt Township
Type of Business/Product: Trading / Medicine
Gender: Male / Female (1)

Job Ref No.: 18P1546
Salary: 1,300,000/- Kyats

Job Requirements

  • Bachelor’s degree in a scientific or related field; Pharmacy degree preferred.
  • Minimum of [5] years of experience in regulatory affairs or a related role.
  • In-depth understanding of regulatory requirements and processes within relevant industries.
  • Proven track record of successful regulatory submissions and approvals.
  • Strong communication and interpersonal skills, with the ability to engage effectively with clients and internal stakeholders.
  • Detail-oriented mindset with a focus on accuracy and compliance.

 

Job Description

  • Client Management:
  • Serve as the main liaison for assigned principals, overseeing all regulatory activities.
  • Collaborate closely with principals to comprehend their regulatory needs and handle FDA inquiries
  • Foster strong client rapport through regular communication and proactive issue resolution.
  • Offer strategic guidance to principals, ensuring the delivery of top-notch regulatory services.
    Regulatory Submissions and Approvals:
  • Conduct comprehensive evaluations of dossiers, documents, and samples during the registration process
  • for Pharmaceuticals, food supplements, cosmetics, and medical devices.
  • Lead the submission process for dossiers, samples, inquiries, letters, and other requisite forms to the FDA, while monitoring timelines.
  • Stay abreast of FDA guidelines and announcements to provide timely regulatory support and counsel to management teams and partner firms.
  • Maintain meticulous records of mandatory documents and data for the registration process.
  • Manage diverse regulatory activities, including NDA applications, renewal registrations, one-time recommendations, and DIAC attachments to the FDA.
  • Demonstrate excellent verbal and written English communication skills, serving as a liaison with international companies to fulfill registration requirements.
    QA Related Matters:
  • Conduct quality assessments of imported products to ensure alignment with company standards and regulatory compliance, while maintaining thorough records.Cross-functional Collaboration:
  • Foster collaboration with stakeholders across regulatory, QA, and supply chain functions.
  • Participate in client meetings and regulatory agency interactions to support company objectives.
  • Provide training and mentorship to junior staff on regulatory processes and best practices.

 

Working Hours: 9:00 AM to 5:00 PM
Holidays: Sunday & Public Holiday

 

How to Apply: Please email to cv@vacjobsearch.com with your Microsoft Word CV file and job title and job ref no. in subject line.

Hotline: 01-8395918,09-765395918

Job Detail
  • Offerd Salary1,000,000 - 1,500,000 MMK
  • Career LevelMid-level Management
  • Experience5 Years
  • GenderBoth
  • INDUSTRYTrading
  • QualificationBachelor
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