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Regulatory Affair Manager

Our Client is the global leader in water, hygiene and energy technologies and services that provide and protect clean water, safe food, abundant energy and healthy environments. Company delivers comprehensive programs and services to the food, energy, healthcare, industrial and hospitality markets in more than 170 countries around the world. With strong services, solutions and expertise, we see tremendous opportunity to further strengthen our relationships with the largest players in global business and help our customers meet their operational challenges anywhere in the world. Company is an Equal Opportunity Employer, relying on the diversity of our workforce to drive innovation and growth.

Position:                     Regulatory Affair Manager

Location:                     President Tower, Ploenchit, Bangkok

Industry type:            Chemical

Job Type:                   Permanent

Salary Range:            up to 150K

Report to:                  Regulatory Director (Expat)

Key Responsibilities:

• Manage product registration and life cycle management ensuring that a company's products comply with the local FDA's regulations
• Define the regulatory affairs strategy and execute local regulatory submission activities in line with the corporate and business strategies to support product launch/ change program (renewal and/or extension).
• Proactively prepare submissions of license variations and renewals to strict deadlines.
• Source for documents and guidelines, meticulously consolidate, file and maintain product technical information.
• Maintain and update all regulatory database for the responsible products, in accordance with health authority requirements and timelines
• Monitor regulatory trends, formal legislation to direct the company policy and strategy regarding product safety requirements
• Handling consumer complaints. Provide advice and warning notice on potential regulatory risks and preventive or corrective measures in advance especially FDA's regulations related concerns
• Specifying storage, labeling and packaging requirements or the responsible products

 Qualifications:

• Bachelor's degree in pharmacy with license
• Minimum 5 years of experience in regulatory affairs in MNC pharmaceutical industry preferable in biological or vaccine products)
• Strong experience in regulatory affairs and FDA's regulations for pharmaceutical products including regulatory product development, product launch / approval, line extension and license maintenance
• Experience in product quality assurance (QA) in pharmaceutical industry is advantage
• Ability to work independent, accountability, and strong communication skill.
• Good command of English and computer literacy

Please submit a brief covering letter and your updated CV which fully details your qualifications and experience including present and expected salary, availability and a recent photograph to marisa.v@orenburg.co.th(Call 086-0599005)

We thank you for your interest in applying for the position and please note that only shortlisted candidates will be contacted for further correspondence.

Candidates are not required to pay a fee to use our services.

Visit our website at: www.orenburg.co.th