Head of Regulatory Affairs, Pharmacovigilance and Post Market Surveillance

• Dec 2022 - Present

Head of Regulatory Affairs

• Sep 2021 - Nov 2022

1. To ensure smooth and effective processing of the local regulatory requirements in accordance with the company's regulatory strategies and plans.2. Execute all regulatory activities including submission of new products or renewals until post-approval monitoring.3. Compile, review, coordination, submission, monitoring, follow up of regulatory submissions to ensure expedited processing in accordance with company time lines and targets.4. Maintain close communication with regulatory authorities and other relevant local regulatory bodies and be up to date with all local regulatory updates and changes and cascade this to the team.5. Initiate respective steps or changes upon receipt of updates or news which may affect existing or planned regulatory submissions to ensure continuity of business.6. Serves as a liaison between regulatory bodies and operating divisions of the company.7. Develop, implement and maintain the required regulatory standards, SOP and resource documents.8. Review and ensure labelling is in compliance with local requirements.9. Anticipate regulatory obstacles and emerging issues throughout the product life cycle.

Regulatory Affairs Pharmacist

• Apr 2018 - Aug 2021

Local Registration (March 2018 - March 2019)1. Sound knowledge with ICH, PIC/s and ACTD Registration Guidelines.2. Proven track record of submission and approval of new generic medicines with most priority review applications. Also, experienced in submission For Export Only (FEO) products.3. Regulatory coordinator for biosimilar product development and registration.4. Approved two (2) clinical trial applications (CTX) for investigator initiated research.5. Experienced in submitting application for addition of listing of medicines into the MOH Formulary.6. Proven timely manner of variation submissions and approval with local authority.7. Attended cross functional meetings to provide regulatory insight to support business goals.8. Active MOPI members.Export Registration (March 2019 - Aug 2021)1. Approved product registration in GCC countries and APAC countries such as Brunei, Philippines, Myanmar, Macau, Hong Kong and provisional registration with Papua New Guinea cover both pharmaceutical and veterinary products.2. Certified, proven and hands on eCTD software (EXTEDO Manager) user for eCTD submission.3. Experience in registering and introducing products in European countries such as Belgium (as distributor) and Central America market such as Costa Rica.4. Communicate with regulatory agencies/competent agents regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification follow-up of submission under review.5. Coordinate, prepare and review regulatory submissions for international projects (Iraq, Sudan, Sri Lanka, etc.).6. Advice project teams on subjects such as pre-market regulatory requirements, export labeling requirements and other related information such as GS1 Barcoding system and etc.

Provisional Registered Pharmacist (PRP)

• Mar 2017 - Mar 2018

The training of pharmacists in the manufacturing sector aims to provide the pharmacists with sufficiently in-depth clarity in understanding the manufacturing of pharmaceutical products and to equip the pharmacists with relevant knowledge and skills required in the industry.

Regulatory Affairs

• Nov 2016 - Mar 2017

1. Involved in Project Align Malaysia and Brunei particularly in Chemistry, Manufacturing, and Controls (CMC) and Technical Term Supply (TTS) documentation - Aligning the information based on 6 parameters set. - Obtaining information from the tracker and various sources and align it with approval from respective TA custodians and Managers. - Obtain TTS document from the Quality Assurance team to compare the info received with the Malaysia current specs of products. Advise the QA Team to update the TTS specs to align with registered specs in MYS. - Creating a database for ease in tracking product specs and variations made to products. 2. Project Archive - Refurbish the documents in the store and in the shared drives for feasibility and ease in finding updated information. - Lighten up the shared drives to speed up the process of finding information , total of 10GB to be removed from shared drives. - Establishing a database on archived products for references in future.

Quality Assurance

• Apr 2016 - Jun 2016

- 3 months internship - Specialization in Production and Quality Assurance (mainly) - Supervised under a very experienced Quality Assurance Manager who had 9-10 years of experience in Quality Management and was given load of task to be completed during my internship. Activities during internship: 1. Amendment of SOP for certain revision number 2. Involved actively in Six Sigma Green Belt Project mainly in batch documentation purposes. 3. Experienced in presentation to the Six Sigma Projects Consultant regarding the findings for the projects. 4. Experienced in preparing Product Quality Review for some medications and able to analyze in details the trend and interpretation of the PQR. 5. Experienced in using Minitab Analytical Software ; ex: preparation of graphs and trends in industry, excel in Microsoft Office Skills 6. Experienced in providing training to the workers in data integrity matters regarding with documentation and details supposed to be filled in Batch Manufacturing Records (BMR) profile.