Herleeza Shee Email & Phone Number

Rawang, My

Sungai Buloh, Selangor, Malaysia

a) Planning, Coordinate & Submission•Perform compilation, review and submission of pharmaceutical generic drug products for new registration and variation application.•Monitor registered drug products for executing the product renewal and discontinuation of the products.b) Collaboration with Internal & External Parties•Collaborate and provide the regulatory consultation with the internal departments and external manufacturing sites.•Ensure every department is aware of the regulatory requirement & that all products comply with the regulations of NPRA.c) Label & Package Insert Development•Involve in the development and discussion of label and package insert for drug products to ensure the compliance with the regulatory authority’s labelling requirements.d) Regulatory Communication• Keep up-dated with any latest announcement and changes in regulatory guidelines such as Drug Registration Guidance Document (DRDG)•Perform effective communication with the regulatory authority pertaining to the correspondences for the new registration and variation submissions.•Closely interact and discuss with internal team to configure the best regulatory strategies in answering the correspondence from the regulatory authority in a timely manner.•Monitor on product complaints received by NPRA after products’approval.•Liaise and negotiate with regulatory authorities for product related registration if needed for improvement or emendation e) Documentation & Compliance •Create and maintain the regulatory database for all registered products to assess the regulatory impact on the products in response to new regulatory requirements.

• Guided the process of legal compounding in lieu with Malaysian Good Compounding Guidelines (2018) and United States Pharmacists’ Pharmacopeia (2008).• Assisted Pharmacist in the document preparation of doctors’ prescription for inspection and filing purposes.• Processed incoming drug order including oral and topical formulations compounding using integrated approach to treat underlying medical conditions.• Carried out laboratory work such as raw material preparation, capsule filing, cream preparation, gel mixing, packing of cream as well as gel into syringe & common lab work.• Monitored & in charge of pharmacy packaging stock to maintain streamlined inventory and low overhead cost.• Supported Pharmacist in compounding formulation for capsule, transdermal cream, gel, troches, syrup, spray or suspension to ensure all the specific needs of patient are addressed.• Focused on Bioidentical Hormone Replacement Therapy (BHRT) such as by addressing the root cause or as a replacement hormones

Kuala Lumpur, Malaysia

Identification & characterization of the structural protein of a bacteriophage highly virulent to Burkholderia pseudomallei & multidrug resistant Pseudomonas aeruginosa".• Culture and sub-culture bacteria strains at mid-log growth phase for effective results.• Independently isolate phage from environment for research purposes.• Identify the most effectives virulent phage to lyse bacterial strains at specific concentration and volume.

Rawang, Selangor, Malaysia

Attain Standard A effluent release with daily sample analysis and leading operators' action to address specific issues.• Reduced operation cost 20% by optimization of chemical dosage using jar test independently.• Research on best microbiological nutrients and supplements for microbial growth and activities. • Achieved good microbial community in the aeration tank for maximum efficiency of the treatment plant.• Successfully reduce sludge carry over which implement the use of double barrier sedimentation tank by proactive researching and experimenting.• Managed 3 new operators' training and 4 current operators with the OSHE team, ranging from equipment maintenance to chemical safety handling, in a professional and personable manner.•Documented in-situ experimental results for food production’s effluents in a proper manner.

Selangor, Malaysia

Dealing with DNA databank management, PCR, genetic analyser, buccal swab and other related work scope.

Bachelor'S Degree, Biotechnology

Science