• Liaising and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers/scientists
• Writing comprehensible, user-friendly, clear product information leaflets and labels
• Ensuring that quality standards are met and submissions meet strict deadlines
• Issues/provides documents (CPR, GMP, LTO, SPC) to clients which are requested by the concerned technical sales specialists or business unit managers
• Review and initiate artwork labels of current and upcoming products
• Back-up Direct Point of Contact (DPOC) for product quality complaints and adverse event reporting

• Managed regulatory changes required by new and revised regulations.
• Communicated complex requirements and identified operational impacts of said regulations.
• Provided technical review of data and reports to ensure scientific rigor, accuracy, and clarity within the department.
• Responsible or invoices, processed payments, and prepared deposits as a vital part of financial operations oversight.

• Responsible for preparation of ANDA documents using e-CTD electronic submission.
• Review and maintain annual and safety reports, supplements, batch records and Certification of Analysis.
• Prepare cover letters and forms such as Form FDA 1571 for regulatory submissions.
• Maintain expertise and understanding in ICH, FDA and IND/NDA submission process. 

• Offering advice about company policies, practices and systems
• Obtaining marketing permission.
• Outlining requirements for labelling, storage and packaging
• Using a variety of specialist computer applications

• Responsible for approval of curriculum’s for licensure of Cosmetology schools.
• Provided technical review of data and reports to ensure rigor, accuracy and clarity of assigned tasks.
• Compiled and maintained regulatory documentation databases of  licensed professionals within the Commonwealth of Virginia. 
• Responsible for maintenance of over 100 confidential client files, licensing applications and compliance records. 
• Effectively served as an advisory resource by providing customer experience expertise.
• Established and maintainted positive relationships with government regulator, residents, families, and community at large. 

• Maintain, update, and submit product registrations and variations at the Food and Drug Administration Philippines and Bureau of Animal Industry
• Responsible for annual license and permit renewal process 
• Responsible for import permit applications
• Responsible for annual and initial submission of vaccine samples required by the Bureau of Animal industry required for product registration
• Regulates label revisions and initial submissions and inform Food and Drug Administration and Bureau of Anima
• Document issuances such as Certificate of Product Registration, License to Operate, and Material Safety Data Sheet requested by different business units
• Administer Regulatory Affairs Department’s databases 

• Regulates all product registrations, cGMP compliance certificates, and establishment licenses of the company
• Monitors changes, receives necessary files needed for variation filing at the Food and Drug Administration Philippines and Bureau of Animal Industry
• Initiates all product sample requests, artworks, and other important documents and coordinates it with Merck/MSD Headquarters
• Regulate all sample submissions of vaccines at the Bureau of Animal Industry
• Collates farm request profiles from respective technical sales specialists and/or business unit managers as required by the Bureau of Animal Industry, and assures all clients have submitted this for compliance
• Applies import permit applications
• Updates all department’s databases, prepare reports and summaries for the Regulatory Affairs Manager

• Studying scientific and legal documents
• Gathering, evaluating, organising, managing and collating information in a variety of formats
• Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)
• Maintaining familiarity with company product ranges
• Planning, undertaking and overseeing product trials and regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Analysing complicated information, including trial data