Regulatory Affairs Consultant, Thailand
<p>Looking for Consultants in RA/QA/PV experienced with commercial regulatory affairs, in classification ranging from pharmaceuticals, biologics, cosmetics, health food, medical devices, hazardous chemicals etc. Fluency in business English + native language is required, including both spoken and written with international experience</p><p>Professionals with relevant experience are welcome to apply, such as regulatory intelligence, strategic planning, clinical trial management, product registration, CMC compliance, life cycle management, pharmacovigilance, quality system management, audits etc.</p>
<h2>Responsibilities</h2>
<p>Business development, project management and execution of projects related to regulatory affairs, Pharmacovigilance and quality assurance with a thorough understanding of regulations and industry practices, open to any scope that may come by in the pharmaceutical Consulting service industry.</p>
<p>Cover end to end all aspects from securing regulatory and compliance projects for the market, strategize and provide solutions to clients in product registration by providing regulatory support and intelligence, review for compliance, translation, submission of dossier to health authority locally or regionally, and following up on post-approval commitments, life cycle management etc. Also to support Quality Management System of Good Distribution / Storage and Supply Practices in Thailand for Marketing Authorization Holding.</p>
<p>Be the local qualified person for Pharmacovigilance reporting and support other PV in the region, where needed.</p>
<h2>Other supporting functions for Company</h2>
<p>To be open to new challenges and new scopes including general management and marketing of the business in Thailand.</p>
<p>Consultant may be tasked with company administrative matters, which involves marketing, branding and business development, managing client and vendors database, organizing / communication on training events etc.</p>
<p>Ability of Consultant to demonstrate interest and initiative in this area for the general process improvement and growth of company will be welcome.</p>
<p>List is not exhaustive and varies with consulting opportunities with lots of growth potential for a challenging and rewarding consulting career.</p>
<h2>Qualifications</h2>
<p>Candidate should have minimum 2 - 3 years of experience doing regulatory affairs, product registration and submissions to the regulatory authorities, pharmacovigilance, Quality system maintenance. Preference for experience from Distribution companies importing foreign pharmaceutical products.</p>
<p>Entrepreneurial, problem solver, self-driven, mature, able to work independently or in dynamic environments, able to manage projects to completion within allocated timeline. Be resourceful and able to seek answers to challenging questions regarding the Asian Regulatory environment.</p>
<p>Bachelor’s degree Pharmacy</p>
<p>We offer full time / project base / part time flexible working conditions, where candidate may work remotely. However candidate must be able to manage projects to completion within timeline given.</p>
<p>Please submit your resume to hr.sg@phameng.com with current salary, benefits, and earliest date of availability.</p>
<p>Resumes to indicate an experience summary table of product classifications handled, dosage forms, product names if applicable, countries covered.</p>
<p>We regret that only qualified applicants will be contacted.</p>
Apply for this position
<h2>Responsibilities</h2>
<p>Business development, project management and execution of projects related to regulatory affairs, Pharmacovigilance and quality assurance with a thorough understanding of regulations and industry practices, open to any scope that may come by in the pharmaceutical Consulting service industry.</p>
<p>Cover end to end all aspects from securing regulatory and compliance projects for the market, strategize and provide solutions to clients in product registration by providing regulatory support and intelligence, review for compliance, translation, submission of dossier to health authority locally or regionally, and following up on post-approval commitments, life cycle management etc. Also to support Quality Management System of Good Distribution / Storage and Supply Practices in Thailand for Marketing Authorization Holding.</p>
<p>Be the local qualified person for Pharmacovigilance reporting and support other PV in the region, where needed.</p>
<h2>Other supporting functions for Company</h2>
<p>To be open to new challenges and new scopes including general management and marketing of the business in Thailand.</p>
<p>Consultant may be tasked with company administrative matters, which involves marketing, branding and business development, managing client and vendors database, organizing / communication on training events etc.</p>
<p>Ability of Consultant to demonstrate interest and initiative in this area for the general process improvement and growth of company will be welcome.</p>
<p>List is not exhaustive and varies with consulting opportunities with lots of growth potential for a challenging and rewarding consulting career.</p>
<h2>Qualifications</h2>
<p>Candidate should have minimum 2 - 3 years of experience doing regulatory affairs, product registration and submissions to the regulatory authorities, pharmacovigilance, Quality system maintenance. Preference for experience from Distribution companies importing foreign pharmaceutical products.</p>
<p>Entrepreneurial, problem solver, self-driven, mature, able to work independently or in dynamic environments, able to manage projects to completion within allocated timeline. Be resourceful and able to seek answers to challenging questions regarding the Asian Regulatory environment.</p>
<p>Bachelor’s degree Pharmacy</p>
<p>We offer full time / project base / part time flexible working conditions, where candidate may work remotely. However candidate must be able to manage projects to completion within timeline given.</p>
<p>Please submit your resume to hr.sg@phameng.com with current salary, benefits, and earliest date of availability.</p>
<p>Resumes to indicate an experience summary table of product classifications handled, dosage forms, product names if applicable, countries covered.</p>
<p>We regret that only qualified applicants will be contacted.</p>