Specialist, Regulatory Affairs

**Specialist, Regulatory Affairs**

**THE OPPORTUNITY**
- Based in Singapore, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
- Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

**WHAT YOU WILL DO**
- Basic Functions & Responsibility (may not be limited to)_
- For assigned products ensures high quality labelling translation and artwork management.
- For assigned products and tasks, stays updated on relevant Singapore and Brunei and local regulations and guidelines.
- Where necessary, engages with other stakeholders e.g. IMQ, Pharmacovigilance and supply chain to manage HA interactions.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
- Major Activities (may not be limited to)_
- Maintenance of licenses for assigned products_
- Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.
- Compliance_
- For assigned products, ensures timely preparation and maintenance of Package Inserts, local HCP letters, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures. Implement package inserts within the correct timeframes for compliance.
- Ensures that all internal customers receive relevant information with regards to the regulatory status of the assigned products.
- Ensures the correct and proper utilization of appropriate our company system tools, to generate mock-up artwork and to implement revisions to artwork.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
- Editing and labelling_
- Ensures package inserts submissions, approvals and record keeping.
- The above-mentioned tasks are performed under supervision of Country Lead/Director Regulatory Affairs, where applicable.
- Artwork development_
- Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
- The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
- Cross-functional activities, as assigned_
- Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
- Adequately supports other functions to enable compliance in areas related to regulatory e.g. tender submissions.

Regulatory environment
- Keeps abreast of local laws.
- Quality and Additional Systems Responsibility_
- Support product recalls activities according to our standards and local procedure. Closely cooperates with Agency, In-Market Quality/ Quality Contact Person (QCP),, SCM and/or PhV, Quality at wholesaler/distributor/importer level and/or to support Management (Crisis) team.
- Manages CPP and CAST to ensure documents are provided to requesting countries as necessary.
- Provide oversight to tenders for in-scope countries and ensure timelines for providing requested documents for tender bids are met.

**WHAT YOU MUST HAVE**

To be successful in this role, you will have:

- A graduate degree in Biological/Chemical Sciences/Pharmacy. Singapore-registered pharmacist is preferred.
- At least 3 years of relevant commercial pharmaceutical regulatory affairs experience and knowledge and the ability to work cross-functionally and independently to drive results.
- A good team player with excellent communication skills and good working attitude.

**WHAT YOU CAN EXPECT**
- Opportunities across various functional group within regulatory affairs
- Exposure to communications across multiple stakeholders