A. Menarini (Thailand) Ltd.

Regulatory Affairs Associate

A. Menarini (Thailand) Ltd.
Salary negotiable
Posted on 01 Mar 2021

Regulatory Affairs Associate

A. Menarini (Thailand) Ltd.

Job Highlights

  • Bachelor’s degree in Pharmacy with license
  • Minimum 3 years in product registration
  • Proficient in oral and written English

Job Description

Reporting to:   Regulatory Affairs Manager

Key Responsibilities (including but not limited to):

Product Registration;

  • Do new products/project assessment at local level and provide product life cycle strategy to management and to regional/global team ((Drug/Food supplement/Medical device/Cosmetic/Natural product/Narcotic/etc).
  • Submitting documents and follow up until obtaining approval for Drug registration (New/Generic, Chemical/Biologic/Natural).
  • Submitting documents and follow up until obtaining approval for Non-Drug registration (Food supplement/Medical device/Cosmetic/Narcotic/etc.).
  • Maintain and keep product registration license update.
  • Manage registered information for marketing requirement.
  • Manage and provide registered information for Thai FDA clearance to Supply chain.

Company Registration;

  • Submitting documents and follow up until obtaining approval for each company license relating to product registration, import and sell. (Drug/Food supplement/Medical device/Cosmetic/Natural product/Narcotic/etc).
  • Maintain and keep company registration license update.
  • Manage/Verify records and reports as require by each company license.

Regulatory information management;

  • Provide regulatory information and regulatory strategy to relevant colleagues, and manages regulatory matters as assigned.

Others;

  • Be a part of QMS responsibility team for ensure product importation, release, complaint handling, recall handling, safety handling are smoothly and effectively.
  • Manage Country Regulatory Affairs’ SOP

Qualifications & Experience:

  • Bachelor’s degree in Pharmacy with license.
  • Minimum 3 years in product registration.
  • Proficient in oral and written English.
  • Computer literacy (Word, Excel, PowerPoint).
  • Accurate, service mind and proactive.
  • Proven good coordinator and communication skills.

Interested applicants, please send your application letter with full resume, expected salaries, and end enclosing a recent photograph to :
A. Menarini (Thailand) Ltd.
63 Athenee Tower, 33th Floor, Wireless Road,
Lumpini, Pathumwan, Bangkok 10330
Contact : Tel. 02-696-8517

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
3 years
Job Type
Full Time, Permanent

Company Overview

Menarini Asia-Pacific is a member of the Menarini Group, the world’s largest Italian biopharmaceutical company, and provides physicians and healthcare professionals with medical and scientific information with competence, correctness and the highest ethical standards in all its work processes”.  Menarini has the heritage of over 130 years and over 17,400 employees in more than 136 countries. Menarini Asia-Pacific’s vision is to be a leading provider of important healthcare brands to improve the lives of people in the region. Menarini Asia-Pacific operates across the entire commercial value chain, from clinical development, regulatory approval and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Consumer Health, Dermatology, Allergy/Respiratory, Cardiovascular, Oncology/Specialty Care and Men’s Health.For further information please visit: www.menarini.com


Additional Company Information

Benefits & Others
Dental insurance, Five-day work week, Life insurance, Medical insurance, Performance bonus, Transportation allowance, Travel allowance