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Regulatory Affairs Consultant

Malaysia · Internal Postings

Openings: 1

<p>We are looking for project / contract based Consultants in RA/QA, experienced with commercial or regulatory affairs, in any 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.</p><p>Professionals with relevant experience in any aspect of regulatory affairs are welcome to apply, such as product registration and variations, CMC compliance and change management, and import/export and CPP management.</p><p><strong>Responsibilities</strong></p><p>Consultant should be versatile and able to support full range of services related to regulatory affairs 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>Projects may vary. Projects may cover end to end all aspects from product registration to 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 may be required to support Pharmacovigilance, Quality Management System of GDP, GDPMD, GMP, Validation etc, where required.</p><p><strong>Other supporting functions for Company</strong></p><p>To be open to new challenges and new scopes including general management and marketing of the business.</p><p>Consultant may be tasked to be involved with company administrative matters, such as 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><strong>Qualifications</strong></p><p>Candidate should have minimum 1 - 2 years of experience doing regulatory affairs, product registration and submissions to the regulatory authorities.</p><p>Be a 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&rsquo;s degree or above in Science, Pharmacy, Biomedical etc may apply &nbsp;</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 apply at this link https://cutt.ly/lexRaRs, and 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>
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