Regulatory Affairs Executive

2 weeks ago

Singapore LABGISTICS ASIA PTE. LTD. Full time

**Responsibilities**:
**Regulatory and Compliance Duties**
- Main liaison with regulatory and government bodies regarding Regulatory works including but not limited to product registrations (including LABG and its customers’ products etc), regulatory related enquiries from internal and external stakeholders and updating of regulatory requirements etc.
- Handle product registrations including review and preparation of product dossiers and both maintenance and filing of current product licenses and registration documents.
- Oversee and track overall product registrations and RA related projects for Singapore and Regional BEs.
- Handle Medical Devices, Radioactive Products, Therapeutic Products and Controlled Drugs related tasks including but not limited to its import, clearance, and release.
- Handle internal department e.g. Sales enquiries, customer enquiries and conduct customer presentations where applicable.
- Manage variations for therapeutic products and change notifications for medical devices etc.
- Plan and coordinate regulatory and classification body audits with relevant authorities, prepare auditees and relevant documentations prior to audits and handle audit follow ups with both internal stakeholders and regulatory authorities.
- Submit reports and transactions of our companies’ assigned licenses and permits as required by respective regulatory authorities.

**Internal Process, Standardisation and Improvement**
- Review current RA processes and product registrations with inter-department stakeholders and implement harmonisation and alignment across Singapore and Regional BEs.
- Ensure relevancy and compliance of our Procedures (SPs/SOPs/WIs) in accordance with local regulations and certification body standards.
- Organize and lead meetings with the local and regional Regulatory Affairs team to review status of registrations, renewals and amendments including projects and other activities of the department.
- Provide monthly and quarterly RA performance reporting to Head of QRA.
- Develop yearly Regulatory budget and planning and conduct quarterly review for reporting purposes.
- Liaise with QA and Operations on the periodic and routine review of logs and records for movement and traceability of products and responsible in handling product recalls.
- Manage complaints including customer and product related complaints and handle FSCA/adverse events/CARs with both internal and external stakeholders where applicable.

**Pharmacovigilance and Training**
- Conduct Pharmacovigilance (PV) training, PV literature screening and provide relevant updates to stakeholders.

**Others**
- Carry out any other duties assigned from time to time by Head of QRA.

**Requirements**:

- Pharmacy Degree registered with Singapore Pharmacy Board, with at least 2 years of working experience as Pharmacist.
- Familiar with the regulatory registration process and requirements for Form A Poison License, Controlled Drug License, Therapeutic Products and Medical Devices Product Registration, Hazardous Substances and Radioactive Products License etc.
- Prior work experience in handling Hazardous Substances and Radioactive Products is a plus.
- Able to communicate fluently in both written and verbal English.
- Able to work both independently and in a team environment.

  • Regulatory Affairs Specialist, Asean

    4 days ago

    Singapore DN & Associates Executive Search Full time

    Our client is a global medical device company and leader in new product development and medical education. They are pioneers in their speciality and every year, develop over a thousand innovative and specialised surgical products. Their mission is simple; to better the lives of the millions of patients using their products worldwide. They are looking for a...

  • Regulatory Affairs Specialist, Asean

    4 days ago

    Singapore DN & ASSOCIATES EXECUTIVE SEARCH PTE. LTD. Full time

    Our client is a global medical device company and leader in new product development and medical education. They are pioneers in their speciality and every year, develop over a thousand innovative and specialised surgical products. Their mission is simple; to better the lives of the millions of patients using their products worldwide. They are looking for a...

  • Regulatory Affairs Manager, Apac

    4 days ago

    Singapore DN & ASSOCIATES EXECUTIVE SEARCH PTE. LTD. Full time

    Our client is an established medical device MNC and they are looking for a Regulatory Affairs Manager to join them in overseeing the APAC region. As their Regulatory Affairs Manager, you will perform regulatory activities and be responsible for managing product registrations and submissions for product lines and / or geographical areas. Additionally, you...

  • Regulatory Affairs Executive

    6 days ago

    Singapore BIOBOT SURGICAL PTE. LTD. Full time

    **Job Description - Regulatory Affairs Executive** - Ensure compliance with applicable regulatory requirements and standards for medical device. - Assist in the drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards. - Prepare and submit regulatory technical...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore EVYD RESEARCH PRIVATE LIMITED Full time

    **JOB TITLE: Regulatory Affairs Specialist **REPORTING TO**:Regulatory Director (Population Health) **IN BRIEF** - Reports to Regulatory Director, responsible for EVYD’s regulatory affairs. - Regulatory affairs largely related to internal processes of medical device and non-medical device projects - Looking at Software as a Medical Device (SaMD) **KEY...

  • Regulatory Affairs Executive

    1 week ago

    Singapore SOMNOTEC (S) PTE. LTD. Full time

    **Major Responsibilities: -**: - Managing Regulatory Affairs for the company including products registration and renewal of existing licenses - Ensuring regulatory and quality assurance compliance according to SOPs - Establishing a close professional relationship and maintaining active dialogue with relevant health authorities - Timely report on all...

  • Regulatory Affairs Executive

    5 days ago

    Singapore The GMP Group Full time

    This position has responsibility for Regulatory Affairs within Malaysia, Singapore and Brunei. This includes: Support regulatory affairs team on other regulatory affairs matters especially those which are required from personnel based in Singapore.Ensure minimal supply disruption from regulatory affairs scopes.Ensure required licenses are maintained and...

  • Regulatory Affairs Specialist

    1 week ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Regulatory Affairs Executive

    2 weeks 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...