Regulatory Chemist

Responsibilities: - ensuring that a company's products comply with the regulations of the Health Authorities - keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to;
- collecting, collating and evaluating scientific data that has been researched by colleagues;
- preparing submissions of licence variations and renewals to strict deadlines; monitoring and setting timelines for licence variations and renewal approvals;
- undertaking and managing regulatory inspections;
- reviewing company practices and providing advice on changes to systems;
- liaising with, and making presentations to, regulatory authorities;
- negotiating with regulatory authorities for marketing authorisation;
- specifying storage, labelling and packaging requirements - Create and maintain product DMFs - Filing of Drug Master files, Common Technical Documents, Technical Packs - Registration with authorities, Answering of queries of authorities and customers Requirements: Demonstrated experience (3+ years). Bachelor's Degree preferably in a technical/scientific discipline e.g.; Chemical; Physical or Biological Sciences; Pharmacy; Microbiology; Engineering with at least 3 years’ experience in Quality Management Systems or Regulatory Affairs
Symbiotica Speciality Ingredients Sdn Bhd is a Technology based, Export oriented, Life Sciences company, manufacturing Active Pharmaceutical Ingredients, with a presence in over 45 countries worldwide, spanning 5 continents. We are located with our corporate office at Prai and Production facility in Kulim, Operating under cGMP guidelines and certified for ISO 9001:2015. Established since 2001, the company has won recognition awards from the Malaysian government over the years. In line with our expansion plans.
Bachelor's or Equivalent