Specialist Jobs 301 Jobs

Please enter a valid email
Done! You will get notified about new matching jobs
Back to your search
Apply Now
Print Report Share View in new tab
13 August 2020
Job ID: BK-238232
Regulatory Affairs Supervisor / Manager

 

Roles and Responsibilities

  • Manage all activities pertaining to product registration and other regulatory approvals, including registration plans and submission strategies, product advertising, product reports, and company license renewals.
  • Complete all documentation for drug, medical devices and cosmetics to be filed and registered mainly at Thai FDA.
  • Partner with team members (i.e. RA, QA, Marketing, Supply chain, etc) to manage the product to be valid with compliance to local regulation (i.e. variation/renewal/GMP clearance submission and approval)
  • Providing support in terms of product importation, prepare all concerned documents to be completed and ready to be submitted for FDA’s consideration i.e. Application form,GMP certificate, COA, COO, Product specification sheet, Certificate of manufacturer, Import license, Labelby ensuring that all documents are aligned with local requirements.
  • Candidates should be able to communicate in English with international colleagues for the exchange of information regarding regulatory affairs. Coordinate with internal and global regulatory team to ensure that the registration dossier, packaging artworks meet the requirements of Thai FDA and properly manage and resolve the issues.
  • Candidates should be able to review and identify impacts from new regulatory guidelines and regulatory trends, monitor changes in regulations, and consider all proper measures needed to complete tasks.

 

Requirements

  • Bachelor degree in pharmacy.
  • Having at least 3 years experience in Thai regulatory affairs and drug ACTD documentation. (experience in medical devices and cosmetics is a plus)
  • Good knowledge of local regulations for drug, medical device & cosmetic registrations.
  • Good interpersonal skills to manage work with colleagues, agencies and regulatory bodies.
  • Good written & spoken English language skills.
  • Confident to respond to rapidly changing situations and ability to take own appropriate action.
  • Being highly-motivated and having enthusiastic personality.
  • Proficiency in Microsoft Office programs

 

Benefits and Remunerations :

  • Salary depends on experiences and qualifications, plus 1- month guaranteed bonus, performance bonus is eligible.
  • Life Insurance, Family health insurance and Dental.
  • Provident Fund and Social Security Fund.
  • Vacation Leave 10 Days / Year.

 

Rohto-Mentholatum (Thailand) Ltd.

317 Kamolsukosol Building, 9th Floor , Unit D-E, Silom Road
Silom, Bangrak, Bangkok 10500

Contact : Khun Cha-aim

Apply Now

Job Details:

Benefits:
  • Five-day work week
  • Performance bonus
  • Medical insurance
  • Dental insurance
  • Life insurance

Rohto-Mentholatum (Thailand) Ltd.
URGENTLY REQUIRED !!! "Rohto-Mentholatum (Thailand) Ltd." ROHTO-MENTHOLATUM (THAILAND)  LTD. is a subsidiary of the joint venture world class health and wellness companies; The Rohto-Pharmaceutical, Japan and The Mentholatum Company, USA. More than 125 years established company dedicates to provide effective solutions and make happy surprises for the consumers all over the world. Our core focus has always been and will continue to be on our consumers, our associates and our societies. Even though we have re-inventedourproducts many times during our history, our core philosophy has not changed. We are thankful that we have the opportunity to serve and create a better world. The Thailand office established since 1996 markets the world leading brands such as LipIce, Mentholatum Lipcare, Mentholatum Acnes, Mentholatum Ointment, Sunplay Suncreen Lotion, Selsun Medicated Anti-Dandruff Shampoo, and Hada Labo, the famous Japanese brand.

Is this your company? Claim it now!