Regulatory Affairs Executive

9 hours ago

Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full time

Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings;
- Communicate changes and new requirements to management;
- Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations;
- Have working knowledge of current products sold and keep abreast of new product launches by having regular update meetings with all the selling division managers;
- Assist Senior Manager, Regulatory Affairs for matters pertaining to regulatory affairs as and when required;
- Communicate with manufacturers, the local regulatory requirements, in order to facilitate the provision of appropriate documents for submission to HSA for product registration/amendments and compliance to local regulations;
- Work with regulatory partners/distributors to obtain successful registration of new products.
- Coordinate, facilitate, monitor, and track all regulatory activities in each market,
- Comply with reporting requirements of local authority
- Regulatory reporting for recalls, FSCAs, Adverse Events and complaint handling;
- Ensure compliance with GDPMDS;
- Ensure conduct of business according to local regulations for medical devices;
- Participate in GDPMDS internal and external audits
- Maintain and update regulatory-related databases, SOP
- Registers complaint with samples to manufacturer. Follow-up on reply from manufacturer.
- Any other duties assigned

**Professional Competencies**:

- General Degree (preferred in discipline of Biomedical Science or Biomedical Engineering)
- Preferred 1 year working experience or completion of Internship in the related field
- Familar with local and regional regulatory affairs requirements (medical devices)

**Personal Competencies**:

- Good interpersonal relationship skills
- Good written and verbal communication skills
- Project Management Skills
- Good organization skills
- Team spirit, Proactive, motivated, self starter

Salary range differs according to seniority.

  • Head of Regulatory Affairs

    7 days ago

    Singapore Keller Executive Search Full time

    The Head of Regulatory Affairs will be responsible for ensuring that our company complies with all relevant regulations and laws. This role requires a deep understanding of the pharmaceutical industry's regulatory environment and involves developing regulatory strategies, overseeing regulatory submissions, and liaising with regulatory bodies. Job...

  • Regulatory Affairs Executive

    5 days ago

    Singapore Superform Consulting Pte Ltd Full time

    Job Title : Regulatory Affairs Executive Location: Tuas **Salary**: $4500-$6000 Working Days: Mon -Fri Working Hours: 7.45AM-4.45 PM Job Duties - Prepare and maintain the registry of all products registered locally and internationally. - Prepare and maintain the markets regulatory requirements for implementation in the company. - Follow-up on any...

  • Regulatory Affairs Executive

    7 days ago

    Singapore Hays Full time

    **Your new company** Join one of the leading pharmaceutical company today! Excellent opportunities for learning in Regulatory Affairs work. **Your new role** - Communicate with regulatory authorities as well as overseas counterparts with regards to regulatory affairs matters such as product registrations, changes in existing products and renewals - Ensures...

  • Regulatory Affairs Executive

    3 days ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Permanent**Salary** - $4,000 - $7,000 Per Month**Date Posted** - 2 hours agoAdditional Details **Job ID** - 113486**Job Views** - 1Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting Regulatory...

  • Regulatory Affairs Executive

    2 weeks ago

    Singapore Hyphens Pharma International Limited Full time

    COMPANY DESCRIPTION **Listed on the Catalist board of the Singapore Exchange (SGX), Hyphens Group has a direct presence in Singapore (HQ), Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering additional jurisdictions like Hong Kong, Myanmar, Brunei, Cambodia, Oman, Bangladesh, South Korea and...

  • Regulatory Affairs Professional

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist RoleWe are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support our regulatory activities.This role will involve assisting with the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.Main Responsibilities:Submission Support: Assist with the...

  • Regulatory Affairs Executive

    9 hours ago

    Singapore Employment Vietnam Full time

    **Summary**: Our client is a UK-based multinational company specializing in the creation of original fragrances and flavors. They are seeking a talented individual to join their team as a Regulatory Affairs Executive Primary **Responsibilities**: - Provide technical documentation to our customers in a timely manner. - Advise customers on products...

  • Regulatory Affairs Executive

    1 day ago

    Singapore NESTLE SINGAPORE PTE LTD Full time

    **A day in the life of...** - Regulatory Compliance (Recipe check, regulatory input on label, label approval, communication materials) - Compliance Check & Review - Label-D System Implementation and Training - Inter Market Supply Product Brief (IMSPB) (SG as Importing Market) - Maintain Documentation - Support Regulatory Projects **What will make you...

  • Regulatory Affairs Executive, Apac

    2 weeks ago

    Singapore Symrise Full time

    **About Symrise AG** Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. Its sales of € 3.8 billion in the 2021 fiscal year make Symrise a leading global provider....

  • Regulatory Affairs

    4 days ago

    Singapore BIOPTIMAL INTERNATIONAL PTE. LTD. Full time

    We are a global leader in manufacturing of medical devices and deliver solutions to improve lives through today’s technology and future innovation. Due to business needs, we are now seeking for multiple experienced Regulatory Affairs executives to be part of our Regulatory Affairs team for ongoing transformation projects due to expansion. **Regulatory...