Business License Management-Supervise the application, validation, and timely renewal of vital corporate documents, including wholesale licenses, manufacturing facility clearances, import/export certificates, and municipal Business Licens
Regulatory Relations: Act as a primary liaison with external regulators, counsel, and service providers regarding license applications, corporate filings, and compliance maintenance.
Collaborate closely with Export countries NRA and manufacturing teams to manage product registration and life cycle management (LCM) for biologicals produced at the Kaohsiung site (e.g., PCV2) across key export markets in Asia (4 countries) and Latin America (8 countries), act as manufacturing RA (MRA), communicate in English.
Execute or support timely submission according to the agreed market operating model, including administrative submission steps and submission evidence where applicable.
An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Specialist to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is an advantage.
Facilitate and follow up on information exchanges with suppliers, ensuring timely submission of regulatory documents, product data, and compliance evidence.
Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for a pharmaceutical, biotech, or CRO organization
Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately and assist in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.
Work with Rollout, Finance, Legal, Commercial and operational teams to ensure regulatory submissions and supporting data are accurate, complete, appropriately approved and supported by an adequate audit trail.
Act as the primary liaison with regulatory authorities, notified bodies, and local registration partners to facilitate timely approvals and address regulatory inquiries.