Regulatory Affairs Consultant

PharmEng Technology, an international leader providing engineering, validation, technology transfer, contract project support (manufacturing and testing), regulatory affairs and GMP compliance services to the Pharmaceutical, Biotechnology, and Medical Device industry is currently recruiting for:Consultant, Regulatory Affairs, Development Chemistry Manufacturing and Control (CMC), R&D Formulation, Quality Assurance in Skin Care, Cosmetics, Hand Sanitizer, Disinfectants, Household, OTC, Consumer range of products Looking for full time Consultants in to support Regional Developmental RA/QA, experienced with Technical Product Development in Hand Sanitizer, Disinfectant Skin Care Cosmetics, OTC Consumer categories, for product line development and expansion.Strong awareness of ASTM, EN and ISO standards in hand sanitizer product development and formulation, able to articulate and provide specifications of standards to support formulation team, to substantiate and defend Efficacy, Toxicology, Safety, Stability studies for regulatory approvalsTo gather technical information necessary to compile a Cosmetic Product Information File (PIF) for regulatory submissions of Hand Sanitizers across Asia and beyond.Communicate across stakeholders in R&D, formulation, manufacturing, and regulatory agencies across exported markets for market access of hand sanitizers, disinfectants and cosmetics.Fluency in business English + native language is required, including both spoken and written.Current urgent need requires the incumbent to have sound personal care experience in Cosmetics, Hand Sanitizers, Skin care category etc, preferably with regional experience. Professionals with relevant experience will be shortlistedThis is a work from home opportunity mainly, but may be deployed on-site if required depending on the project requirements. ResponsibilitiesConsultant 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. Other supporting functions for Company To be open to new challenges and new scopes including general management and marketing of the business.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.Ability of Consultant to demonstrate interest and initiative in this area for the general process improvement and growth of company will be welcome. QualificationsCandidate should have minimum 2 - 3 years of experience doing formulation development, understand the test specifications and requirements of Hand Sanitizer category, and support regulatory affairs, product registration and submissions to the regulatory authorities in export markets.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.Bachelor’s degree or above in Science, Pharmacy, Pharmaceutical Sciences, Biomedical etc may apply   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.Please apply at this link <a href="https://www.pharmeng.asia/career" target="_blank">https://www.pharmeng.asia/career</a> and submit your resume to hr.sg(at)phameng.com with current salary, benefits, and earliest date of availability.Resumes to indicate an experience summary table of product classifications handled, dosage forms, product names if applicable, countries covered.We appreciate your application, but regret that only qualified applicants will be contacted.