Regulatory and Government Affairs Specialist

**Summary of Role**

This position is responsible for the following:
Management of the Company’s compliance in accordance with relevant regulations governing drugs and devices, in line with the strategic objectives of the company.

Provide support for all quality related matters eg managing quality management system (eg GDP & GDPMDS) in accordance to HSA technical specifications

**Key Accountabilities**

**Regulatory Affairs Role**
- Responsible to support business strategic launch activities towards Company’s compliance according to Health Products & Therapeutic Products Act in Singapore.
- Manage submissions requirements through the regulatory management database (RMD).
- Maintain drug and device registration files, technical files, resources, relevant legislations and projects for Singapore & Brunei.
- Provide input and support to AP Quality Regulatory Environment Management (APQREM) team & local business team to manage Regulatory Affairs budget, change orders for medical devices & drugs
- Provide updates & maintain database to APQREM on the registration status of devices & drugs.
- Participate in monthly meetings & conference calls with local business teams & APQREM to provide inputs & suggestions on ongoing registration projects status.
- Create, maintain & update registration/customs clearance database, license information, quality certificates, safety data sheets for all local relevant departments (eg business, 3rd party logistics service provider & supply chain).
- Review the promotional material, co-ordinate the approval process within the organization in order to comply with the HSA medical device sales & advertisement promotion guidance
- Ensure that redressing activities are carried out in accordance to GMP requirements & work with 3rd party to ensure that all aspects of redressing are met to ensure adherence to HSA license and GMP requirements

**Quality Affairs Role**
- Assume responsibility for co ordination of activities from initiation to closure within local/APQREM teams (eg APQREM, business teams, supply chain team & technical teams)
- Responsible for reporting to HSA for adverse events, recalls & Field Safety Corrective Actions (FSCA) in relation to edical devices & drugs.
- Responsible for reporting to HSA for adverse drug reaction (ADR), adverse events (AE), Field Safety Corrective Actions (FSCAs) & recalls.
- Maintain & update all relevant SOPs & Site Master File (SMF) in relation to GDP & GDPMDS HSA technical specifications.
- Conduct internal audits within technical, business, supply chain & 3rd party logistics service provider.
- Responsible for reporting product quality complaints for medical devices & drugs, monitoring & flagging out any deviation of possible quality issue to APQREM, business & management teams.
- Co ordinate with 3rd party logistics & supply chain to ensure compliance to GDP & GDPMDS in terms of returns & disposal of medical devices & drugs
- Work with 3rd party logistics service provider to ensure that storage & handling of FME medical devices & drugs are in accordance to manufacturer’s indications.
- Responsible for maintaining Importer & wholesaler license for medical devices & drugs to ensure compliance to HSA GDP & GDPMDS technical specifications.
- Address & close of Corrective Action Preventive Actions (CAPA) for major non conformities (NC) upon completion of any GDPMDS certification body (CB) external audits or GDP HAS external audits
- Follow through minor NC & areas of improvement upon conclusion of any internal & external audits for GDPMDS certification body (CB) external audits & GDP HSA external audits within the relevant local teams (eg business, supply chain, 3rd party logistics service provider, technical teams)

**Government Affairs**
- Oversees, coordinates and leads specific GA projects and government key interactions at country level among governments, international institutions, trade associations and other bodies who influence the healthcare operating environment.
- Develops and maintains tools or processes delivering this expertise in a manner that meets regulatory and evidentiary requirements, including (a) to ensure efficient material content access, (b) to share best practice examples of government affairs advocacy and market access/business cases, and (c) to ensure follow up and applied leverage of cross market best practices
- Provide strategic and tactical guidance to ensure the countries’ business priorities and opportunities are reflected in the overall strategic and tactical planning.

**Qualifications and Experience**
- Degree in Engineering & Scientific Discipline
- 2-3 years’ experience in regulatory affairs in the device and pharmaceutical industry.
- Proven track record of successful registration of devices and pharmaceuticals in Singapore and extensive knowledge of Health Science Authority’s regulatory system.

**Competencies**
- Team player with good interpersonal skills and ability to work with mínimal superv