Regional Regulatory Affairs Officer Asia
2 weeks ago
Main Accountabilities
- Represent Regulatory Affairs on various cross-functional teams
- Contribute to the development of project plans and other deliverables
- Document Control
- Create and revise procedures as needed
- Review and approve change orders and evaluate for submission requirements
- Internal Audits coordination and support
Tasks
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements
- Compiles all dossiers required in submissions, license renewal and GMP clearance renewal.
- Monitors and maintain database of registration and status – ensure proper filing and records of regulatory documentation are kept.
- Keeps abreast of regulatory procedures and changes.
- Recommends strategies for earliest possible approvals of applications.
- Effective communication between global, HQ RA to ensure implementation of all strategic plans.
- Lead and drive RA activities in accordance with local requirements to ensure the Company’s products are registered on time or life cycle management in the markets are in scope of responsibility, and post marketing surveillance risks are minimized.
- Responsible for Regulatory monitoring and analysis of new or updated local legislation and for assuring in-time registration in the relevant countries.
- Create a regulatory plan and a labelling plan (when needed) to ensure consistency.
- Improve efficiency of RA team to create a cogentprocess of documents/data management / storage and / or document flow which is easy and efficient for access to relevant stakeholders.
- To provide training and knowledge sharing session to the Company’s associates and distributor to ensure all parties understand and comply to all relevant local regulations.
- Responsible to monitor distributor’s competencies in regulation activities, and to provide effective solution to ensure quality RA work could be carried out.
Requirements
- Strong knowledge of local regulatory requirements including submissions requirements, labelling and regulations, auditing principles and adverse event reports
- Minimum 2 years of related experience
- Bachelor’s degree in Pharmacy or Science related qualification
- Strong writing, editing and analytical skills
- Some Pharmacovigilance exposure will be a bonus
Candidates with more experience and ability to handle more complex operations may be considered at a manager level.
Tell employers what skills you have
Multi Tasking
document control
Legislation
Work Well Under Pressure
Regulatory Affairs
Audits
Managing Ambiguity
Organization Skills
Team Player
Regulatory Requirements
Regulatory Submissions
Pharmacovigilance
Ability to Prioritize
-
Regional Regulatory Affairs Officer Asia
2 weeks ago
Singapore Vifor Pharma Asia Pacific Pte. Ltd. Full timeMain AccountabilitiesRepresent Regulatory Affairs on various cross-functional teamsContribute to the development of project plans and other deliverablesDocument ControlCreate and revise procedures as neededReview and approve change orders and evaluate for submission requirementsInternal Audits coordination and supportTasksPerforms the coordination and...
-
Regulatory Affairs Executive
1 day ago
Singapore LABGISTICS ASIA PTE. LTD. Full timeRoles & ResponsibilitiesThis role is part of LABGISTICS Asia Pte Ltd's (LABG) Quality and Regulatory Affairs (QRA) department under the Commercial Support Services Division. The job holder will provide strategic direction and alignment for the Regulatory Affairs (RA) function, working closely with Quality Assurance (QA) function to ensure compliance at our...
-
Regulatory Affairs Manager
4 weeks ago
Singapore Integrity Partners Pte. Ltd. Full timeAs a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.Role OverviewLead the coordination of submission...
-
Regulatory Affairs Manager
3 weeks ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & ResponsibilitiesAs a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.Role Overview Lead the...
-
VP, Regulatory Affairs
4 weeks ago
Singapore RXILIENT MEDICAL PTE. LTD. Full timeRoles & ResponsibilitiesPosition: Vice President, Regulatory AffairsGeographical Focus: Southeast Asia and Taiwan, expanding to the MENA marketResponsibilities: Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and...
-
VP, Regulatory Affairs
4 weeks ago
Singapore Rxilient Medical Pte. Ltd. Full timePosition: Vice President, Regulatory AffairsGeographical Focus: Southeast Asia and Taiwan, expanding to the MENA marketResponsibilities:Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global markets.Craft...
-
Regulatory Affairs
5 days ago
Singapore Mead Johnson Nutrition (singapore) Pte. Ltd. Full timeResponsibilities:Assist Regulatory Affairs Director in providing regulatory activities and product safety support for Reckitt products (Health, Nutrition and Hygiene category).Lead the on-going regulatory compliance, notification, and registration of Reckitt products.Lead and co-ordinate the resolution of regulatory including Code of Ethics movement,...
-
Regional Regulatory Affairs Manager
2 days ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & ResponsibilitiesYou will be handling a portfolio of pharmaceutical products covering crucial therapeutic areas and managing regulatory activities across the ASEAN region.MAIN RESPONSIBILITIES Utilize exceptional interpersonal skills and influence to establish strong relationships with stakeholders and develop effective regulatory strategies for the...
-
Regulatory Affairs Specialist
2 weeks ago
Singapore Access-2-healthcare Full timeCompany DescriptionAccess-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing expertise to doctors,...
-
Singapore EASMED ASIA PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities1. Product Registration Manage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission. Handle the maintenance and renewal of Product Registration License for Singapore and/or various...
-
Regional Medical Affairs Director
7 days ago
Singapore Gmp Technologies (s) Pte Ltd Full timeGMP is partnering with a leading pharmaceutical company dedicated to advancing healthcare through innovative medicines and therapies to identify a Medical Affairs Director to help lead their Asia Pacific region . With a focus on patient-centricity and scientific excellence, our client strives to improve patient outcomes and enhance quality of life across...
-
Regulatory Affairs Executive
3 days ago
Singapore Oculus Private Limited Full timeResponsibilities:Prepare product technical dossiers for regulatory submissionUnderstand labelling requirements in multiple region and manage artwork used in product packagingLiaise with relevant parties to resolve product registration and regulatory issuesMaintain document control of technical file, quality procedures and work instructions for the purpose of...
-
Regional Medical Affairs Director
5 days ago
Singapore GMP TECHNOLOGIES (S) PTE LTD Full timeRoles & ResponsibilitiesGMP is partnering with a leading pharmaceutical company dedicated to advancing healthcare through innovative medicines and therapies to identify a Medical Affairs Director to help lead their Asia Pacific region . With a focus on patient-centricity and scientific excellence, our client strives to improve patient outcomes and enhance...
-
Regional Regulatory Affairs Manager
1 week ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & ResponsibilitiesKEY RESPONSIBILITIES Utilize exceptional interpersonal skills and influence to establish strong relationships with stakeholders and develop effective regulatory strategies for the long term. Manage the product lifecycle and regional submission pipelines in an efficient manner, leveraging technical and strategic expertise. Ensure...
-
Regional Regulatory Affairs Manager
2 weeks ago
Singapore Integrity Partners Pte. Ltd. Full timeYou will be handling a portfolio of pharmaceutical products covering crucial therapeutic areas and managing regulatory activities across the ASEAN region.MAIN RESPONSIBILITIESUtilize exceptional interpersonal skills and influence to establish strong relationships with stakeholders and develop effective regulatory strategies for the long term.Manage the...
-
Singapore BASF SE Full timeObjectives of the PositionReporting to the global Vice President Seeds and Traits Regulatory Affairs, this role is a key member of the global Regulatory, Sustainability & Public Affairs leadership community, working closely with peers, and the Senior Vice President for Regulatory, Sustainability and & Public Affairs. It also serves as a member of the...
-
Singapore Easmed Asia Pte. Ltd. Full timeResponsibilities1. Product RegistrationManage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission.Handle the maintenance and renewal of Product Registration License for Singapore and/or various countries, ensuring adherence to...
-
Regional Regulatory Affairs Manager
7 days ago
Singapore Integrity Partners Pte. Ltd. Full timeKEY RESPONSIBILITIESUtilize exceptional interpersonal skills and influence to establish strong relationships with stakeholders and develop effective regulatory strategies for the long term.Manage the product lifecycle and regional submission pipelines in an efficient manner, leveraging technical and strategic expertise.Ensure that all regulatory processes...
-
Regulatory Affairs Associate
1 day ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...
-
Regulatory Affairs Associate
3 weeks ago
Singapore Pharmeng Technology Pte. Ltd. Full timePharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective...