Regulatory Affairs Executive

Reports To

Regulatory Affairs Executive will report to Assistant Regulatory Manager.

Job Summary

• Achieved DRCs, DIACs for pharmaceuticals, IRs and cosmetic notifications for FMCG products in MMFDA.
• Currently handling clients of 6 both pharmaceuticals and FMCG products across 5 countries in Asia and Europe.
• Competent administrative professional supporting the underwriting process with effective document evaluation, report writing and file management skills.
• Proficient in online submission for new registrations, gathering details and reviewing renewal requests.
• Expedited for dossier checking and preparation for registration.

Responsibilities and Duties

Key duties of the job include:

• studying scientific and legal documents
• gathering, evaluating, organising, managing and collating information in a variety of formats
• ensuring compliance with regulations set by Myanmar FDA (MM FDA)
• maintaining familiarity with company product ranges
• planning, undertaking and overseeing product trials and regulatory inspections
• keeping up to date with changes in regulatory legislation and guidelines
• analysing complicated information, including trial data
• offering advice about company policies, practices and systems
• outlining requirements for labelling, storage and packaging
• using a variety of specialist computer applications
• liaising and negotiating with regulatory authorities
• providing advice about regulations to manufacturers/scientists
• writing comprehensible, user-friendly, clear product information leaflets and labels
• ensuring that quality standards are met and submissions meet strict deadlines
• preparing documentation for Registration, Import License and Retail License.

Qualifications and Experience

• University Degree in Pharmaceutical Science or Science or related field
• Two or more years experienced with regulatory affairs in the medical and pharmaceutical field

Language Skills and Other Skills

• English
• Computer Skills
• Legal Knowledge skills
• Management skills
• Administrative skills
• Communication Skills
• Strategic Planning skills
• Problem Solving skills
• Technical Skills

• Certificate, License, Others

  MS Office Suite, Adobe Photoshop CS3, Adobe PageMaker 7