Regulatory Submissions

**Responsibility**: - Under the direction of senior staff, assist with the formatting and compilation of regulatory submissions through such tasks as entering information into Tables of Contents and creating tabs and submission labels. - Provide support assistance to senior staff in the upkeep of regulatory authority submission and correspondence logs (add...

Roles & ResponsibilitiesJob DescriptionRoles and Responsibilities: Perform ICSR submission activities to China health authority. Perform submission activities within agreed timelines with high quality with adherence to regulatory guidelines and applicable standards, and processes. Perform other functional duties associated with local case reporting/ E2B;...

Roles & ResponsibilitiesOur client is a highly reputed MNCResponsibilitiesPerform ICSR submission activities. Perform submission activities within agreed timelines with high quality with adherence to regulatory guidelines and applicable standards, and processes. Perform other functional duties associated with local case reporting/ E2B;...

**~Responsibilities**: Manages interface with Affiliate/Agency for key projects/issues Implements regulatory strategies for assigned projects for countries Represents the regulatory function at sub-teams or client group meetings to present regulatory requirements or provide strategic input for the registration of products. **Requirements**: Minimum 3...

**Job Description**: Including but not limited to: - Regulatory dossier review and submission - Liaison with internal and external regulatory stakeholders - Provide strategic input on regulatory strategirs to achieve acceleration Handles all regulatory aspects Job Requirement: - Experience in Singapore Regulatory Agency submission, Biologics submission -...

**Salary**: up to $5500 **Duration**: 1 year contractWorking Days & Hours: Mon-Fri Office HoursLocation: Tuas - Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc. - Provide advice on submission...

Job Summary: We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in the Singapore office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your...

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...

*** The Regulatory Affairs Specialist has the responsibility to Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for registration submissions in Singapore, Malaysia and rest of ASEAN countries. Adheres...

**Position**: Vice President, Regulatory Affairs **Geographical Focus**: Southeast Asia and Taiwan, expanding to the MENA market **Key Responsibiliites**: - Craft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen focus on guiding projects from initial concept to market delivery. - Direct and...

The company I’m representing is a leading consumer healthcare MNC with a good presence globally. They are looking for a Regulatory Affairs Specialist to help with their product registrations across the ASEAN region. This incumbent would have opportunities for career progression internally. **Responsibilities**: - To prepare and track overall regulatory...

**RESPONSIBILITES** - To track and oversee Regulatory Projects & Timelines using Microsoft Project Management Software; to monitor potential bottle necks and to highlight to Supervisor to devise resolution methodology. - To research and obtain regulatory information from Authorities, Associations and Consultants for existing countries or new emergent...

This position will be responsible for leading and coordinating regional regulatory registrations. Managing all facets of regulatory support for all segments products and assist in administration work pertaining to activities in regulatory affairs to support regional registration priorities. **Principal Duties and Responsibilities**: - Oversee the APAC...

The company I’m representing is a leading consumer healthcare MNC with a good presence globally. They are looking for a Regulatory Affairs Specialist to help with their product registrations across the ASEAN region. This incumbent would have opportunities for career progression internally. **Responsibilities**: - To prepare and track overall regulatory...

**Responsibilities**: - Manage the regulatory submission process by ensuring timely supply of supporting information and regulatory dossier review to achieve timely approval from regulatory authorities. - Manage questions from regulatory authorities concerning a regulatory submission by ensuring timely supply of response and supporting information to...

Sr. Spclst, Regulatory Affairs - ** Based in Singapore**, the regional hub for **Asia Pacific (AP) **and **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...

The individual Contributor will be based in the Singapore office and is responsible for working with Global Regulatory Teams and head office-based team members (e.g. Business Development Team) to define and implement country-specific regulatory strategy for assigned products. This incumbent will report remotely to the Distribution Regulatory Affairs...

Roles & ResponsibilitiesRoles & ResponsibilitiesThe RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and...

**Responsibilities**: - Manage the regulatory submission process by ensuring timely supply of supporting information and regulatory dossier review to achieve timely approval from regulatory authorities. - Manage questions from regulatory authorities concerning a regulatory submission by ensuring timely supply of response and supporting information to...

**Position**:REGULATORY ASSISTANT (1 vacancy - immediate) **Job Description (all processes will be taught in-house)**: - Co-ordination and online submission of various formatted documentation to the Health Sciences Authority (Ministry of Health) - Formatting of medical dossiers documents - Checking for accuracy in verification and validation of reports -...